[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SWOG Cancer Research Network\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":575},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,45,72,93,115,125,149,171,194,218,243,265,286,307,326,346,366,385,407,434,460,483,503,529,548],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100054308","phase-2-testing-mosunetuzumab-alone-with-zanubrutinib-or-with-polatuzumab-vedotin-for-treating-marginal-zone-lymphoma-that-came-back-or-didnt-get-better-with-treatment-100054308",false,"NCT07638722","Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment","MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed\u002FRefractory Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL.\n\n  * NOTE: A repeat biopsy to confirm MZL diagnosis is NOT required at time of relapse unless:\n\n    * The participant has received prior CD3\u002FCD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease is required after the completion of the prior CD3\u002FCD20 bispecific antibody therapy and prior to study registration.\n    * The participant has splenic MZL in which a bone marrow biopsy pre-registration is required within 42 days prior to registration\n* Participants must have measurable disease by PET-CT (preferred), or CT as defined by extranodal lesion ≥ 1cm or nodal lesion ≥ 1.5cm.\n\n  * Participants with splenic MZL are included in the study if spleen standardized uptake value (SUV) (or any splenic masses) is \\> liver (standardized uptake value) SUV background and\u002For spleen size is \\> 13cm.\n  * Participants must have staging imaging performed within 42 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the neck, chest, abdomen, and pelvis, are acceptable. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants must have one or more of the following criteria for further systemic therapy as per the discretion of the treating physician:\n\n  * Symptoms due to progressive or bulky nodal disease.\n  * Progressive disease that is currently compromising or may compromise normal organ function if left untreated.\n  * Presence of systemic B symptoms (i.e. fevers, weight loss, night sweats).\n  * Presence of symptomatic extranodal disease.\n  * Cytopenias due to bone marrow infiltration or hypersplenism.\n  * An increase in the tempo of disease progression\n* Participants must not have known or clinically suspected transformation to diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Participants with prior transformed disease but now in relapse with MZL only are allowed on study\n* Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first eight cycles (6 months) of protocol therapy\n* Participants must have relapsed\u002Frefractory MZL after at least one line of prior CD20-directed systemic therapy (either as monotherapy or in combination with chemotherapy or lenalidomide).\n\n  * Prior antibiotic and radiation treatments for localized MZL disease are allowed and do not count as one line of systemic therapy\n* Participants who have been treated with prior Bruton's tyrosine kinase inhibitor (BTKi) or CD3\u002FCD20 targeting bispecific antibodies for their MZL must have completed treatment 180 days prior to registration and must have received a best response of either a partial or complete response\n* Participants being treated with strong and moderate CYP3A4 inducers must be off these therapies within 14 days or 5 half-lives of the drug prior to registration, whichever is shorter\n* Participants must have recovered (\\\u003C grade 2) from any side effects of prior therapy, except for alopecia and lymphopenia\n* Participants must not have been treated with prior polatuzumab vedotin for any condition\n* Participants must not have received chimeric antigen receptor T-cells (CAR-T) within 28 days prior to registration\n* Participants must not have received autologous stem cell transplantation within 100 days prior to registration\n* Participants must not have received allogeneic stem cell transplantation within 180 days prior to registration nor have active graft versus host disease requiring the current use of systemic steroid treatment ≥ 10mg of prednisone (or equivalent)\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (defined as equivalent to ≥ 10mg prednisone) or other immunosuppressive medications within 7 days prior to registration.\n\n  * NOTE: Replacement steroid therapy for adrenal or pituitary insufficiency or short-term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is permitted\n* Participants must not have known clinically active post-transplant lymphoproliferative disorder\n* Participants must not have a known history of severe allergic reaction attributed to compounds of similar chemical or biologic composition to mosunetuzumab SQ, zanubrutinib or polatuzumab vedotin\n* Participants must not have received either primary or booster vaccination with live or attenuated vaccines within 28 days prior to registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod Performance Status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count ≥ 1.0 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow involvement or a known\u002Fdocumented Fy (A-\u002FB-) immunophenotype by completed duffy antigen phenotyping (i.e. \"Duffy-Null\") must have absolute neutrophil count (ANC) ≥ 0.5 x 10\\^3\u002FuL. Growth factor use is allowed\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow or splenic involvement must have platelets ≥ 50 x 10\\^3\u002FuL\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench\n* Participants must have an international normalized ratio (INR) \\\u003C 2 x ULN within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better, in the opinion of the treating physician\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 180 days prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 180 days prior to registration, if indicated. Participants with a positive hepatitis (Hep) B core antibody are at high risk for reactivation and should receive prophylactic antiviral therapy (e.g., entecavir) before initiation of and throughout the duration of protocol treatment\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 180 days prior to registration, if indicated\n* Participants must not have any known uncontrolled intercurrent illness (in the opinion of the treating physician) that would jeopardize the participant's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, peripheral neuropathy, hypertension and gastrointestinal disorders affecting swallowing and\u002For absorption of pills\n* Participants must not require or be receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days prior to registration\n* Participants must not have a history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* Participants must not have a history of stroke or intracranial hemorrhage within 180 days prior to registration\n* Participants must not have a history of progressive multifocal leukoencephalopathy\n* Participants must not have uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","ALL","18 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.",[27,28,29,30,31,32],"Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Recurrent Nodal Marginal Zone Lymphoma","Recurrent Splenic Marginal Zone Lymphoma","Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Refractory Nodal Marginal Zone Lymphoma","Refractory Splenic Marginal Zone Lymphoma","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-10-03",{"date":41,"type":21},"2035-04-03",{"name":43,"class":44},"SWOG Cancer Research Network","NETWORK",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100622424","phase-3-adding-biotherapy-or-placebo-to-standard-treatment-for-advanced-kidney-cancer-100622424","NCT07383441","Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer","Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]","Inclusion Criteria:\n\n* Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study\n* Participants must have measurable\u002Fevaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment during the first cycle of therapy\n* Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study\n* Participants must not plan to take any over the counter probiotic supplements at time of study registration and while on protocol treatment\n\n  * NOTE: Vitamin and electrolyte or mineral supplements are permitted\n* Participants must not have had prior systemic therapy for advanced or metastatic RCC or any treatment with immune based combination therapy\n\n  * NOTE: Participants can have prior neo\u002Fadjuvant treatment with an anti-PD-1, anti-PD-L1, and\u002For anti-CTLA-4 antibody or other therapies for any current or prior malignancy if \\> 12 months prior to registration\n* Participants must not be receiving steroid replacement therapy for adrenal insufficiency greater than 50 mg daily of hydrocortisone or prednisone equivalent dose at the time of registration\n* Participants must not require the use of systemic corticosteroids \\> 10 mg\u002Fday of prednisone or its equivalent for any reason other than replacement therapy for adrenal insufficiency\n* Participants must not have received any systemic antibiotics within 7 days prior to registration\n\n  * NOTE: Uncontrolled infections must be completely resolved\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have a Zubrod performance status 0-2 within 28 days of registration\n* Participants must be able to safely receive at least one of the standard of care regimens, per the current Food and Drug Administration (FDA)-approved package inserts, treating investigator's discretion, and institutional guidelines\n\n  * NOTE: Participants with favorable risk as defined by the International Metastatic RCC Database Consortium (IMDC) must plan to receive one of the TKI+ immunotherapy treatment combinations. They are not able to receive regimen 1 (ipilimumab + nivolumab) for this study\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants must have serum creatinine ≤ 2 x ULN (upper limit of normal). This specimen must have been drawn and processed within 28 days prior to registration\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to registration)\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration) Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional ULN (\\\u003C 5 x institutional ULN if liver metastases are present) (within 28 days prior to registration)\n* Participants must have alkaline phosphate measured as a part of the liver function assessment within 28 days prior to registration\n* Participants must have albumin corrected calcium measured within 28 days prior to registration\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have any known history of an autoimmune disease that prohibits the use of immune checkpoint therapy\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who have the ability to complete questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":53,"type":21},718,[55],"PHASE3","This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.",[58,59,60,61],"Advanced Clear Cell Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","RECRUITING","2026-06-09",{"date":65,"type":37},"2026-06-11",{"date":67,"type":37},"2026-06-05",{"date":69,"type":21},"2034-01-31",{"name":43,"class":44},41,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100609869","phase-3-adding-pirtobrutinib-to-the-usual-treatment-for-people-with-newly-diagnosed-richter-transformation-the-piramid-trial-100609869","NCT07220187","Adding Pirtobrutinib to the Usual Treatment for People With Newly Diagnosed Richter Transformation, The PIRAMID Trial","A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)","Inclusion Criteria:\n\n* Participants must have been diagnosed with Richter Transformation (RT) (CLL\u002Fsmall lymphocytic lymphoma \\[SLL\\] to LBCL)\n\n  * Participants must have histologically or cytologically confirmed LBCL\n* Participants must have measurable disease determined by PET\u002FCT or hematopathology (by morphology or flow cytometry) assessment within 42 days prior to registration\n* Participants must have staging PET\u002FCT imaging performed within 42 days prior to registration\n* Participants are allowed prior treatments for CLL\u002FSLL or its complications (autoimmune hemolytic anemia \\[AIHA\\], immune thrombocytopenic purpura \\[ITP\\]), with the exception of pirtobrutinib\n* Participants must not have prior treatment for Richter transformation except for corticosteroids up to equivalent dose of prednisone 700 mg total for less than 7 days for disease control. Treatment for CLL\u002FSLL with CLL\u002FSLL directed drugs (including BTK inhibitors with the exception of pirtobrutinib) after the Richter transformation diagnosis is allowed for the purpose of disease control. CLL targeted therapies must be stopped within 3 days before initiation of therapy on protocol. Chemotherapy or anti-CD20 monoclonal antibody therapy must be stopped within 2 weeks before initiation of therapy on protocol\n* Participants must not have contraindication for receiving anthracycline. Participants must not have received more than a cumulative dose of 100mg\u002Fm\\^2 in those participants who will receive R-CHOP or not more than 250 mg\u002Fm\\^2 in those participants who will receive R-mini-CHOP of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration)\n* Patients requiring strong CYP3A inducers are not eligible and can only be enrolled if\n\n  * an alternative treatment to the strong CYP3A inducer is available for them and\n  * the last dose of the strong CYP3A inducer is administered at least 7 days before initiation of pirtobrutinib for patients in safety run-in and arm 1\n* Participant must be ≥ 18 years old at the time of registration\n* Participant must have Eastern Cooperative Oncology Group (ECOG)\u002FZubrod Performance Status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count (ANC) ≥ 0.75 x 10\\^3\u002FµL or ≥ 0.50 x 10\\^3\u002FµL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Platelets ≥ 50 x 10\\^3\u002FµL or ≥ 30 x 10\\^3\u002FµL in participants with suspected marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL) or ≥ 6 g\u002FdL in participants with suspected bone marrow involvement considered to impair hematopoiesis (within 28 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN with documented liver involvement and\u002For Gilbert's disease (within 28 days prior to registration)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 × institutional ULN or ≤ 5 ULN with documented liver involvement (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For the Cockcroft-Gault formula for calculated creatinine clearance, see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* Participants must have a left ventricular ejection fraction (LVEF) ≥ 45% as measured by echocardiogram or radionuclide (MUGA) ventriculography within 56 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Participants' HIV-directed therapy cannot have known interactions with pirtobrutinib\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants must not have a prior or concurrent malignancy in addition to CLL\u002FSLL and Richter transformation whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have had major surgery within 28 days prior to registration\n* Participants must not have experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n\n  * NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants must agree to have blood and lymphatic tissue specimens submitted for the integrated translational medicine study\n* For randomized participants only: Participants who can complete PRO-CTCAE and FACIT GP5 questionnaires forms in English or Spanish must be offered the opportunity to participate in the patient-reported outcome",{"count":80,"type":21},102,[55],"This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.",[84,85,86],"Richter Syndrome","Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma","Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma",{"date":65,"type":37},{"date":89,"type":21},"2026-08-31",{"date":91,"type":21},"2036-10",{"name":43,"class":44},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100482388","phase-3-comparing-combinations-of-drugs-to-treat-newly-diagnosed-multiple-myeloma-ndmm-when-a-stem-cell-transplant-is-not-a-medically-suitable-treatment-100482388","NCT05561387","Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment","A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of \"Intermediate Fit\" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance","Inclusion Criteria:\n\n* Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration\n* Participants must have measurable disease within 28 days prior to registration as defined by any of the following:\n\n  * Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \\[M-protein\\] level \\>= 0.5 gram\u002Fdeciliter \\[g\u002FdL\\] or urine M-protein level \\>= 200 milligram\\[mg\\]\u002F24 hours\\[hrs\\]); OR\n  * IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \\>= 0.2 g\u002FdL or urine M-protein level \\>= 200 mg\u002F24 hrs); OR\n  * Light chain multiple myeloma (serum immunoglobulin free light chain \\>= 10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio)\n* All disease must be assessed and documented on the baseline\u002Fpre-registration tumor assessment form\n* Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http:\u002F\u002Fwww.myelomafrailtyscorecalculator.net\u002F) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration\n* For Participants Meeting \"Frail\" Status:\n\n  * Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible\n* For Participants Meeting \"Frail\" Status:\n\n  * Hemoglobin \\>= 7 g\u002FdL (must be performed within 28 days prior to registration)\n\n    * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)\n* For Participants Meeting \"Frail\" Status:\n\n  * Platelets \\>= 50 x 10\\^9\u002FL (must be performed within 28 days prior to registration)\n\n    * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)\n* For Participants Meeting \"Frail\" Status:\n\n  * Absolute neutrophil count (ANC) \\>= 0.75 x10\\^9\u002FL (must be performed within 28 days prior to registration)\n\n    * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)\n* For Participants Meeting \"Intermediate Fit\" Status, one or more of the following criteria must be present:\n\n  * Kidney dysfunction showing calculated creatinine clearance (CrCl) \\\u003C30 ml\u002Fmin.\n\n    * Actual lab serum creatinine value with a minimum of 0.7 mg\u002FdL.\n  * Participants must have bone marrow function assessed and meet the below criteria ranges:\n\n    * Hemoglobin between 7-8 g\u002FdL, OR\n    * Platelets between 50-75 x10\\^9\u002FL, OR\n    * ANC between 0.75-1 x10\\^9\u002FL\n\n      * Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)\n  * Revised International Staging System (R-ISS) stage III disease\n  * Note: All labs must be performed within 28 days prior to registration\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography\u002Fcomputed tomography (PET\u002FCT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET\u002FCT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.\n* Total bilirubin =\\\u003C 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 × institutional ULN (within 28 days prior to registration)\n* Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4\n* Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \\> 7\n* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration\n* All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration\n* Participants must have an Eastern Cooperative Oncology Group (ECOG)\u002FZubrod performance status score of 0-2 (Note: Participants with ECOG\u002FZubrod performance score \\[PS\\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system\n* Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n\nExclusion Criteria:\n\n* Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:\n\n  * An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or\n  * Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or\n  * Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.\n* Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration\n* Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \\> 140 mmHg or diastolic blood pressure (DBP) \\> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\\\u003C 140 and DBP =\\\u003C 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.",{"count":101,"type":21},510,[55],"This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.",[105],"Plasma Cell Myeloma","2026-06-08",{"date":108,"type":37},"2026-06-10",{"date":110,"type":37},"2023-10-12",{"date":112,"type":21},"2031-05-30",{"name":43,"class":44},397,{"id":116,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":25,"conditions":119,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100643099",{"count":20,"type":21},[24],[27,28,29,30,31,32],{"date":108,"type":37},{"date":39,"type":21},{"date":123,"type":21},"2029-07-31",{"name":43,"class":44},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100642839","phase-2-testing-blinatumomab-with-or-without-revumenib-in-patients-with-b-cell-acute-lymphoblastic-leukemia-with-a-genetic-change-requiring-more-treatment-100642839","NCT07636564","Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment","A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)\u002F Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)","Inclusion Criteria:\n\n* COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation\n* COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \\\u003C 5%\n* COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)\n\n  * Participants must not be known not to have trackable clones by clonoSEQ\n  * Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment\n* COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage\n* COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)\n* COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)\n\n  * Participants with either B or T-cell subtypes of ALL are permitted on Cohort B\n  * Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)\n* COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction\u002Fconsolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \\\u003C 18 years of age, enrollment must occur after induction therapy\n* COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction\u002Fconsolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications\n* COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies\n* COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below\n\n  * Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy\n* COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL\n* COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit\n* COHORT A: Participant must have Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky\u002FKarnofsky performance status scores of 50-100\n* COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT A: Absolute neutrophil count ≥ 1 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)\n* COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)\n* COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT A: Adequate renal function for participants \\\u003C 18 years of age is defined as:\n\n  * A GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods:\n\n    * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009)\n    * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)\n* COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as \\> 450 msec on screening electrocardiogram (EKG) prior to registration\n* COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement\n* COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator\n* COHORT A: Participants must not have clinically significant autoimmune disease\n* COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric\u002Fgastrostomy (NG\u002FG)-tube is acceptable as long as oral solution is used\n* COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:\n\n  * Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)\n\n    * Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1\n  * Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors\n* COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* COHORT B: Participant must be ≥ 55 years old at the time of registration\n* COHORT B: Participant must have Zubrod\u002FECOG performance status of 0-2\n* COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT B: GFR ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT B: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN\n* COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)\n* COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and\u002For methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy\n* COHORT B: Participants must not have an active uncontrolled infection\n* COHORT B: Participants must not have prolonged QTcf defined as \\> 450 msec participants on screening EKG prior to registration\n* COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain\u002Feye involvement or hypothalamic syndrome\n* COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG\u002FG-tube is acceptable as long as oral solution is used\n* COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n  * This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation","1 Year",{"count":134,"type":21},90,[24],"This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.",[138,139,140,141],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia","2026-06-03",{"date":63,"type":37},{"date":145,"type":21},"2026-10-14",{"date":147,"type":21},"2032-04-16",{"name":43,"class":44},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100488627","phase-2-comparing-combinations-of-targeted-drugs-for-advanced-non-small-cell-lung-cancer-that-has-egfr-and-met-gene-changes-a-lung-map-treatment-trial-100488627","NCT05642572","Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)","A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)","Inclusion Criteria:\n\n* Patients must meet all SCREENING\u002FPRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II\u002FIII Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)\n* Participants must have been assigned to S1900G by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900G is determined by the LUNGMAP protocol\n* Participants must have documentation of NSCLC with a sensitizing EGFR mutation and have radiologically or clinically progressed (in the opinion of the treating physician) on osimertinib, alone or in combination with other agent(s), as their most recent line of therapy. Any number of prior lines of therapy is allowed\n* Participants must have a MET amplification determined by tissue-based or blood-based (circulating tumor DNA \\[ctDNA\\]) next generation sequencing (NGS) assay. MET amplifications may have been determined based on tissue submitted for testing by Foundation Medicine Inc (FMI) through the LUNGMAP screening protocol or using test results completed outside of the study. Tissue or blood must be obtained after disease progression on osimertinib (alone or in combination with another agent\\[s\\]). The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002FIndependent Ethics Committee (IEC), College of American Pathologists (CAP), or similar certification\n\n  * Note: Participants previously tested for and determined to have MET amplified NSCLC, at the time of progression on osimertinib, outside of LUNGMAP, must also submit tissue for central FMI testing on the LUNGMAP screening protocol, if available\n* Participants must have either measurable disease or non-measurable disease documented by CT or MRI. The CT from a combined PET\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study randomization. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable\n* Participants must have a CT with contrast or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization\n* Participants with symptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be neurologically stable and have a stable or decreasing corticosteroid requirement for at least 5 days before sub-study randomization\n* Participants must have recovered (=\\\u003C grade 1) from any side effects of prior therapy, except for alopecia and vitiligo\n* Participants must be able to swallow tablets whole\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Hemoglobin \\\u003C 9.0 g\u002FdL (within 28 days prior to sub-study randomization)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to sub-study randomization). Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional ULN. Participants with history of liver metastasis must have AST =\\\u003C 5 x ULN (within 28 days prior to sub-study randomization)\n* Participants must have a serum creatinine =\\\u003C the IULN OR calculated creatinine clearance \\>= 50 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization\n* Participants must have an electrocardiogram (ECG) performed, with a Fridericia's Correction Formula (QTcF) =\\\u003C 470 msec, within 28 days prior to sub-study randomization. It is suggested that a local cardiologist review the QTcF intervals\n* Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization\n* Participants must have a urinalysis performed 28 days prior to sub-study randomization. Participant must have a urinary protein =\\\u003C 1+ on dipstick or routine urinalysis (UA). Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria \\>= 2+, then a 24-hour urine is to be collected and demonstrate \\\u003C 2000 mg of protein in 24 hours to allow participation in the study\n* Participants must have an International Normalized Ratio (INR) =\\\u003C 1.5 seconds above the institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days to sub-study randomization. Participants must have a partial thromboplastin time (PTT) =\\\u003C 5 seconds above the 'institutional upper limit of normal (IULN) (unless receiving anticoagulation therapy) documented within 28 days prior to sub-study randomization\n* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load within 6 months prior to sub-study randomization\n* Participants must have asymptomatic serum amylase =\\\u003C 2 x ULN and serum lipase =\\\u003C ULN obtained within 28 days prior to sub-study randomization. Asymptomatic is defined as having no signs and\u002F or symptoms suggesting pancreatitis or pancreatic injury (e.g. elevated P. amylase, abnormal imaging findings of pancreas, etc.)\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* Participants with impaired decision-making capacity must not have a neurological or psychological condition that precludes their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator). For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n\nExclusion Criteria:\n\n* Participants must not have received an anti-VEGF or VEGFR inhibitor or MET inhibitor\n* Participants must not have received any anti-cancer drug (investigational or standard of care drug, except osimertinib) within 21 days prior to sub-study randomization\n\n  * Note: osimertinib may continue up to the day prior to study treatment initiation\n* Participants must not have received any radiation therapy within 14 days prior to sub-study randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable\n* Participants must not have received strong inducers of CYP3A4 (including herbal supplements such as St. John's Wort); CYP3A4 inhibitors; CYP1A2 substrates; P-gp and BCRP substrates; sensitive substrates of MATE1 and MATE2K; or drugs that are known to prolong QT interval within 7 days prior to sub-study registration and must not be planning to use any of these throughout protocol treatment\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":157,"type":21},66,[24],"This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and\u002For ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and\u002For ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer.",[161,162],"Recurrent Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","2026-06-01",{"date":142,"type":37},{"date":166,"type":37},"2023-05-05",{"date":168,"type":21},"2028-06-30",{"name":43,"class":44},454,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100637663","phase-3-adding-surgery-and-radiation-to-the-usual-treatment-for-her2-positive-breast-cancer-that-had-already-spread-at-diagnosis-100637663","NCT07578116","Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis","Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy","Inclusion Criteria:\n\n* REGISTRATION STEP 1 - SCREENING \\& INITIAL TREATMENT:\n* Participants must have histologically confirmed de novo metastatic (i.e. American Joint Committee on Cancer \\[AJCC\\] stage IV, no prior history of breast cancer) HER2+ breast cancer with 1 to 5 distant metastatic lesions (oligometastatic). Metastatic breast cancer must be histologically confirmed through biopsy of a distant metastatic lesion unless it is not feasible or safe to biopsy a metastatic lesion, then there must be unequivocal evidence of metastasis on imaging and laboratory studies. HER2+ status must be confirmed in the breast tumor and distant metastatic site as defined per NCCN guidelines version 4.2025\n\n  * NOTE: If HER2 positivity at metastatic site is equivocal due to limitations in HER2 analysis in bone, or it is not feasible or safe to biopsy the metastatic lesion, then HER2 positivity based on breast tumor only is acceptable. If there is no breast lesion, HER2+ must be confirmed in at least one metastatic site\n* Participants with brain metastases are eligible if they meet all of the following criteria at baseline:\n\n  * There are 5 or fewer intracranial lesions\n  * Each intracranial lesions is no larger than 2cm in longest dimension\n  * NOTE: The brain is counted as 1 distant site towards the oligometastatic definition. Brain imaging is not required for participants who have no neurological signs or symptoms suggestive of central nervous system (CNS) involvement; however, assessment of neurological symptoms and brain MRI is strongly encouraged to rule out CNS disease\n* Participants must have no known leptomeningeal disease\n* Participants must meet one of the following criteria prior to Step 1 registration:\n\n  * Treatment naïve and planning to initiate standard of care systemic HER2+ targeted treatment OR\n  * Have already initiated standard of care systemic HER2+ targeted treatment and have completed at least one (≥ 1) but no more than three (≤ 3) cycles prior to enrollment, without progression\n\n    * NOTE: Standard of care scans for baseline disease assessment must have been performed within 28 days prior to initiation of treatment\n* Participants must not be receiving or planning to receive any investigational systemic therapy during study before disease progression\n* Participants must not have received whole brain irradiation\n\n  * NOTE: Participants with up to five brain metastases may have received SRS\u002FSRT either before or after initiation of systemic therapy. If lesions are small and asymptomatic and the participant is receiving CNS penetration they may be managed with observation\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must be able to safely receive the physician's choice of standard of care systemic HER2+ targeted treatment per the current Food and Drug Administration (FDA)-approved package insert(s), treating physician's discretion, and institutional guidelines\n* Participants must be candidates for definitive surgical and radiotherapeutic management of locoregional disease opinion per the discretion of the treating physician\n* Participants must be able to receive ablative dose stereotactic body radiation therapy (SBRT) to all metastatic lesions identified at baseline, in the opinion of the treating physician\n* Participants must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations\n* REGISTRATION STEP 2 - COHORT ASSIGNMENT AND RANDOMIZATION:\n* COHORT A: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT A: Participants must have standard of care (SOC) staging scans and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT A: Participants must have experienced partial or complete response in the breast (in the opinion of the treating physician) following 12-24 weeks of initial systemic therapy based on staging scans performed within 14 days prior to Step 2 registration\n\n  * Participants with breast lesion(s) at diagnosis must have a clinical response on breast imaging per the treating physician\n  * Metastatic lesions, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) and bone response criteria, must have at least stable disease\n  * Brain metastases treated with SRS\u002FSRT must have at least stable disease as per Response Assessment in Neuro-Oncology Brain Metastases (RANO BM) and must not require steroid treatment\n  * Participants with no known breast lesions at diagnosis must have at least partial response in the metastatic sites as assessed by RECIST and bone response criteria\n  * NOTE: The same imaging modality must be used as in Step 1\n* COHORT A: Participants must be eligible for definitive surgical and radiotherapeutic management of locoregional disease per the discretion of the treating physician\n* COHORT A: Participants must not have metastatic lesions that are not amenable to ablative dose stereotactic body radiation therapy (SBRT)\n\n  * Lung lesions that completely resolve after systemic therapy will not be targeted with SBRT, as it is not possible to achieve dose build-up\n  * The development of new sclerotic bone lesions after systemic therapy is not to be interpreted as disease progression, and all such lesions should be targeted with SBRT\n* COHORT B: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT B: Participants must have standard of care (SOC) staging and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT B: Participants must experience clinically stable disease or progression following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n\n  * Participants must have progression in metastatic lesions as assessed by RECIST and bone response criteria or may have stable disease in metastatic lesions by RECIST and bone response criteria if there is progression or no clinical response in the breast\n  * Participants with known breast lesion must have progression or no clinical response on breast imaging as per the treating physician\n  * NOTE: The same modality must be used as in Step 1",{"count":179,"type":21},562,[55],"This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and\u002For chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.",[183,184,185],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic HER2-Positive Breast Carcinoma","Oligometastatic Breast Carcinoma","2026-05-22",{"date":188,"type":37},"2026-05-27",{"date":190,"type":21},"2027-03-09",{"date":192,"type":21},"2033-05-31",{"name":43,"class":44},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100639015","phase-3-testing-short-course-radiation-versus-standard-course-radiation-for-soft-tissue-sarcomas-that-need-surgery-and-radiation-100639015","NCT07615049","Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation","Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma","Inclusion Criteria:\n\n* Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer \\[AJCC\\] 8th edition) soft tissue sarcoma is required\n\n  * Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease \\> 1cm in longest dimension (stage II-IIIB)\n* Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and feet\n\n  * Participants with primary sites of trunk, head, neck, or intra-abdominal, intrapelvic, or retroperitoneal region are not eligible\n  * Participants with extension of the primary tumor into adjacent regions (e.g. torso, hands, feet) are eligible\n* Participants must have an MRI of the primary site within 90 days prior to randomization. The MRI field of view must contain the entirety of the tumor (may be accomplished with multiple MRI scans). MRI must contain axial acquired T1 weighted with fat suppression, T1 weighted sequence with gadolinium contrast with fat suppression, and T2 weighted fat suppression sequence\n* Participants must have no evidence of metastatic disease by CT imaging of the chest (or positron emission tomography \\[PET\\] CT), within 28 days before randomization\n\n  * Given the lack of specificity of chest CT, pulmonary nodule(s) ≤ 5 mm without a histological diagnosis are not exclusionary\n  * Participants with pulmonary nodule(s) measuring 6-10 mm on chest CT are eligible if the nodules appear stable compared to prior chest imaging from at least 6 months ago, or if an fludeoxyglucose F-18 (18FDG)-PET scan indicates that the nodules are unlikely to be metastatic disease\n  * Pulmonary nodules \\> 10 mm should be considered metastatic unless proven otherwise by biopsy\u002Fresection or stable appearance for at least 6 months on imaging\n* Participants must not have fungating tumor. (i.e., tumor breakthrough of skin)\n* Participants must not have myxoid liposarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, gastrointestinal stromal tumor, osteosarcoma, neurotrophic tyrosine receptor kinase (NTRK)-rearranged spindle cell neoplasm, desmoplastic small round cell tumor, Ewing sarcoma, or sarcoma arising from bone\n* Participants must not have known brain metastases. Brain imaging studies are not required for eligibility if the participant has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease\n* Participants must have been evaluated by a surgeon, and it must have been determined that they are a good candidate for a limb salvage resection with an expectation of negative margins, within 35 days prior to randomization. Anticipated positive margins on fixed critical structures are allowed\n* Participants must not have had prior treatment for the current tumor (systemic therapy, radiation, or complete surgical resection)\n* Participants must not have had prior radiation to the anatomical site\n* Participants must be ≥ 18 years old at the time of randomization\n* Participants must have Zubrod performance status of 0-2\n* Participants must have medical history and physical exam within 28 days prior to randomization. History and physical examination must include a description of the location of the tumor, including lateralization and extremity\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must not have uncontrolled intercurrent illnesses or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants registered by sites located in the United States only must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":202,"type":21},296,[55],"This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.",[206,207,208,209,210],"Recurrent Soft Tissue Sarcoma of the Trunk and Extremities","Resectable Soft Tissue Sarcoma of the Trunk and Extremities","Soft Tissue Sarcoma of the Trunk and Extremities","Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8","Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8",{"date":212,"type":37},"2026-05-29",{"date":214,"type":21},"2026-12-02",{"date":216,"type":21},"2030-04-30",{"name":43,"class":44},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100592861","phase-3-studying-chemotherapy-with-or-without-panitumumab-for-unresectable-locally-advanced-or-metastatic-pancreatic-cancer-without-kras-mutations-100592861","NCT06998940","Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations","Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas\n* Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002FInternational Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status\n\n  * NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria\n* Participants must have documented unresectable and\u002For metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis\n\n  * NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status\n* Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).\n\n  * NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment\n* Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.\n\n  * Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment\n  * Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut\u002FMb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.\n  * Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1\u002F2 or PALB2 mutations does not count as a line of therapy.\n* Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)\n* Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)\n* Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization\n* Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label\n* Participant must be ≥ 18 years old at the time of randomization\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Absolute neutrophil count ≥ 1.0 x 10\\^3\u002FuL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor \\[G-CSF\\] or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., G-CSF or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n\n  * Note: Use of growth factor support (e.g., G-CSF or romiplostim \\[Nplate\\]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)\n* Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":226,"type":21},94,[55],"This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil \\[5-FU\\] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.",[230,231,232,233,234],"Locally Advanced Pancreatic Adenocarcinoma","Metastatic Pancreatic Adenocarcinoma","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Adenocarcinoma","2026-05-19",{"date":186,"type":37},{"date":238,"type":37},"2026-05-13",{"date":240,"type":21},"2030-12",{"name":43,"class":44},274,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100351102","phase-2-lung-map-a-master-screening-protocol-for-previously-treated-non-small-cell-lung-cancer-100351102","NCT03851445","Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer","LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)","5.1 Registration\n\nStep 0:\n\n1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see Section 15.3). These patients must be registered to Step 0 to obtain a patient ID number for the submission.\n\n   Patients registered to Step 0 are not registered to the LUNGMAP protocol. To participate in LUNGMAP, patients must be registered to Step 1 after evaluation of patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step 1.\n\n   Patients registered at Step 0 must use the same SWOG patient ID for registration at Step 1.\n\n   Step 1:\n2. Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and\u002For fine-needle aspiration. Disease must be Stage IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell lung cancer should be established using the current WHO\u002FIASLC-classification of Thoracic Malignancies. All histologies, including mixed, are allowed.\n3. Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.\n\n   These criteria are:\n   1. Screening at progression on prior treatment:\n\n      To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV) and must have progressed during or following their most recent line of therapy.\n      * For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1 therapy for Stage III disease, disease progression on consolidation anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the date or initiation of such therapy.\n      * For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or anti-PD-1\u002FPD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab).\n   2. Pre-Screening prior to progression on current treatment:\n\n   To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or anti-PD-1\u002FPD-L1 therapy, alone or in combination (e.g. Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study assignment until they progress and the LUNGMAP Notice of Progression is submitted.\n4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume.\n\n   * The local interpreting pathologist must review the specimen.\n   * The pathologist must sign the LUNGMAP Local Pathology Review Form confirming tissue adequacy prior to Step 1 registration.\n\n   Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If FFPE slides are to be submitted, at least 12 unstained slides plus an H\\&E stained slide, or 13 unstained slides must be submitted. However, it is strongly recommended that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS) will be repeated if done outside this study for sub-study assignment.\n\n   Patients must agree to have any tissue that remains after testing retained for the use of sub-study Translational Medicine (TM) studies at the time of consent the patient is enrolled in.\n5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have progressed following all standard of care targeted therapy. EGFR\u002FALK\u002FROS\u002FBRAF testing is not required prior to Step 1 registration, as it is included in the Foundation One testing for screening\u002Fpre-screening.\n6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within 28 days prior to Step 1 registration.\n7. Patients must be ≥ 18 years of age.\n8. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.\n9. Patients must be willing to provide prior smoking history as required on the LUNGMAP Onstudy Form.\n10. As a part of the OPEN registration process (see Section 13.4 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n11. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n12. U.S. patients who can complete the survey and the interview by telephone or email in English must be offered participation in the S1400GEN Survey Ancillary Study if local institution's policies allow participants to receive the Amazon gift card (see Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must still participate in the main study.",{"count":251,"type":21},10000,[24,55],"This screening and multi-sub-study randomized phase II\u002FIII trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.",[255],"Previously Treated Non-Small Cell Lung Cancer","2026-05-14",{"date":258,"type":37},"2026-05-18",{"date":260,"type":37},"2019-02-06",{"date":262,"type":21},"2029-01-28",{"name":43,"class":44},1229,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100563470","phase-2-adding-the-immunotherapy-drug-cemiplimab-to-usual-treatment-for-people-with-advanced-non-small-cell-lung-cancer-who-had-previous-treatment-with-platinum-chemotherapy-and-immunotherapy-an-expanded-lung-map-treatment-trial-100563470","NCT06616584","Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II\u002FIII Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)","Inclusion Criteria:\n\n* Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol\n* Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration\n* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization\n* Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and\u002For consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:\n\n  * If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease\n  * If they experienced disease progression more than (\\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n* Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy\n* Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease\n* Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen\n* Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met\n* Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization\n* Participants must not have received prior therapy with docetaxel for this disease\n* Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study\n* Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Hemoglobin ≥ 9.0 g\u002FdL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN\n* Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization\n* Participants must have a urinary protein test performed within 28 days prior to randomization\n* Participants' most recent Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization\n* Participants must have a completed medical history and physical exam within 28 days prior to randomization\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated by the treating investigator\n* Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Participants must not have any history of primary immunodeficiency\n* Participants must be able to safely receive study therapy and must not have experienced the following:\n\n  * Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous\u002Fnonexfoliative rash\n  * Any unresolved grade 2 immune-mediated adverse event\n  * Any toxicity that led to permanent discontinuation of prior anti-PD-1\u002FPD-L1 immunotherapy\n  * Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed\n* Participants must not have any history of organ transplant that requires use of immunosuppressives\n* Participants must not have received a live or live attenuated vaccine within 28 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed\n* Participants must not have clinical signs or symptoms of active tuberculosis infection\n* Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\u002Finterstitial lung disease\n* Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization\n* Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization\n* Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization\n* Participants must not have any grade III\u002FIV cardiac disease as defined by the New York Heart Association criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia\n* Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization\n* Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1\u002F2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer\n* Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants\n* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":273,"type":21},378,[24,55],"This phase II\u002FIII Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.",[161,162],"2026-05-04",{"date":279,"type":37},"2026-05-05",{"date":281,"type":37},"2025-05-22",{"date":283,"type":21},"2028-12-31",{"name":43,"class":44},386,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100525049","phase-2-targeted-treatment-for-advanced-non-small-cell-lung-cancer-that-has-increased-copies-of-the-met-gene-an-expanded-lung-map-treatment-trial-100525049","NCT06116682","Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has Increased Copies of the MET Gene (An Expanded Lung-MAP Treatment Trial)","A Phase II Study of Amivantamab SC (Subcutaneous) in Participants With MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)","Inclusion Criteria:\n\n* Participants must have been assigned to S1900J by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900J is determined by the LUNGMAP protocol\n* Participants must have documentation of NSCLC with MET amplification determined by FMI tissue-based next generation sequencing (NGS) assay\n* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document measurable disease ONLY if it is of diagnostic quality: otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration to be considered measurable\n* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration\n* Participants with asymptomatic CNS metastasis (brain metastases or leptomeningeal disease) must be clinically stable and asymptomatic for at least 14 days prior to sub-study registration\n\n  * NOTE: Participants can be on a low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 14 days prior to study treatment\n* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, MET Exon-14 skipping mutant NSCLC, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation\n* Participants must have progressed (in the opinion of the treating physician) following the most recent line of therapy\n* Participants must have received at least one line of systemic treatment for Stage IV or recurrent NSCLC\n* Participants must have recovered (≤ Grade 1) from any side effects of prior therapy. The exception is if a side effect from a prior treatment is known to be permanent without expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or cisplatin neurotoxicity)\n* Participants must not have been previously treated for any cancer with MET tyrosine kinase inhibitors (TKIs) such as tepotinib, capmatinib, and crizotinib\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration\n* Participants must not have a prior treatment with anti-PD-1 or anti-PD-L1 antibody within 6 weeks of sub-study registration\n* Participants must not have received any radiation therapy within 14 days prior to sub-study registration\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 28 days prior to sub-study registration, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study\n\n  * NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to sub-study registration)\n* Hemoglobin \\>= 10.0 g\u002FdL (within 28 days prior to sub-study registration)\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to sub-study registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to sub-study registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN. Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN (within 28 days prior to sub-study registration)\n* Participants must have a serum creatinine ≤ the institutional upper limit of normal (IULN) or calculated creatinine clearance ≥ 45 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration. For creatinine clearance formula see the tools on the CRA Workbench\n* Participants' most recent Zubrod performance status must be 0-2 and be documented within 28 days prior to sub-study registration\n* Participants must have a completed medical history and physical exam within 28 days prior to sub-study registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study registration\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study registration\n* Participants with known diabetes as determined by the treating investigator must show evidence of controlled disease within 14 days prior to sub-study registration\n* Participants of reproductive potential must have a negative serum pregnancy test within 7 days prior to sub-study registration\n* Participants must not have other clinically active infectious liver disease\n* Participants must not have clinically significant hypertension within 28 days prior to sub-study registration as determined by the treating investigator\n* Participants must not have a history of pneumonitis that required drug therapy or an active symptomatic interstitial lung disease (ILD)\u002Fpneumonitis, including drug-induced or radiation ILD\u002Fpneumonitis\n* Participants must not have ongoing or active infection or be diagnosed or suspected viral infection as determined by the treating investigator. NOTE: Participants that have an infection requiring antimicrobial therapy will be required to complete antibiotics 1 week prior to starting treatment\n* Participants must not have active bleeding diathesis as determined by the treating investigator\n* Participants must not have impaired oxygenation requiring continuous oxygen supplementation as determined by the treating investigator\n* Participants must not have psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements as determined by the treating investigator\n* Participants must not have any ophthalmologic condition that is unstable in the opinion of the treating investigator\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\n  * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":294,"type":21},88,[24],"This phase II Expanded Lung-MAP treatment trial tests how well amivantamab-subcutaneous (SC) works in treating patients patients with MET amplification non-small cell lung cancer. Amivantamab-SC is a drug that reduces extra copies of the MET gene, a change present in your tumor. Giving amivantamab-SC may lower the chance of the growth or spread of advanced non-small cell lung cancer that has extra copies of the MET gene in the tumor.",[298],"Lung Non-Small Cell Carcinoma",{"date":300,"type":37},"2026-05-06",{"date":302,"type":37},"2024-11-19",{"date":304,"type":21},"2028-05-31",{"name":43,"class":44},248,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":325},"100518526","phase-2-targeted-treatment-for-advanced-non-small-cell-lung-cancer-that-has-a-met-exon-14-skipping-gene-change-an-expanded-lung-map-treatment-trial-100518526","NCT06031688","Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)","Inclusion Criteria:\n\n* Participants must have been assigned to S1900K by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is determined by the LUNGMAP protocol\n* Participants must have documentation of stage IV or recurrent NSCLC with a MET exon 14 skipping mutation determined by tissue-based or blood-based (circulating tumor DNA \\[ctDNA\\]) next generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)\u002F International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Documentation must either be:\n\n  * NGS test results from tissue submitted for LUNGMAP screening, or\n  * Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a MET exon 14 skipping mutation from a previously completed tissue or blood-based NGS test\n* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document measurable disease ONLY if it is of diagnostic quality, otherwise, it may be used to document non-measurable disease only. Measurable disease must be assessed within 28 days prior to sub-study randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study randomization to be considered measurable\n* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization\n* Participants must not have leptomeningeal disease, spinal cord compression or brain metastases unless:\n\n  * Metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 3 days following the stereotactic radiation and\u002For 14 days following whole brain radiation, and prior to sub-study randomization, AND\n  * Participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study randomization\n* Participants must not have other known actionable oncogenic alterations, such as (but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2 mutation, KRAS activating mutations, and BRAF V600E mutation\n* Participants who have received at least one line of systemic treatment for stage IV or recurrent NSCLC must have progressed (in the opinion of the treating physician) following the most recent line of therapy. Participants who have not yet received systemic treatment for their stage IV or recurrent NSCLC are allowed\n* Participants may have received any number of lines of therapy for stage IV or recurrent NSCLC (including zero) and must be able to report prior treatment information\n* Participants must have recovered (=\\\u003C grade 1) from any side effects of prior therapy for NSCLC except alopecia and vitiligo\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization\n* Participants must not have received treatment with prior MET inhibitor therapies (e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).\n* Participants must not have received treatment with prior angiogenesis inhibitor therapies (including but not limited to bevacizumab and ramucirumab)\n* Participants must not have a history of interstitial lung disease that required steroid treatment\n* Participants must not have received any radiation therapy within 7 days prior to sub-study randomization with the exceptions of\n\n  * Stereotactic radiation to CNS metastases which must have been completed at least 3 days prior to sub-study randomization and\n  * Palliative radiotherapy to bone metastases which must have been completed at least 1 day prior to sub-study randomization\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Absolute neutrophil count \\>= 1.5 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Hemoglobin \\>= 9.0 g\u002FdL (within 28 days prior to sub-study randomization)\n* Platelets \\>= 100 x 10\\^3\u002FuL (within 28 days prior to sub-study randomization)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to sub-study randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 × institutional ULN. Participants with history of liver metastasis must have AST and ALT =\\\u003C 5 x ULN (within 28 days prior to sub-study randomization)\n* Participants must have a serum creatinine =\\\u003C the institutional upper limit of normal (IULN) or calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization\n* Participants must have a cystatin C test performed to obtain baseline value within 28 days prior to sub-study randomization\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization\n* Participants must have a completed medical history and physical exam within 28 days prior to sub-study randomization\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to sub-study randomization\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to sub-study randomization, if indicated by the treating investigator\n* Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis\n* Participants must not have grade \\\u003C 0 of peripheral edema within 28 days prior to sub-study randomization\n* Participants must not have experienced any arterial thromboembolic events, including but not limited to transient ischemic attack or cerebrovascular accident within 6 months prior to sub-study randomization\n* Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to sub-study randomization\n* Participants must not be pregnant or breastfeeding (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must also be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\n  * NOTE: Participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","18 Minutes",{"count":316,"type":21},56,[24],"This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.",[161,162],{"date":279,"type":37},{"date":322,"type":37},"2024-08-08",{"date":304,"type":21},{"name":43,"class":44},266,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":345},"100517853","phase-3-comparing-dara-vcd-chemotherapy-plus-stem-cell-transplant-to-dara-vcd-chemotherapy-alone-for-people-who-have-newly-diagnosed-al-amyloidosis-100517853","NCT06022939","Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis","A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloidosis","Inclusion Criteria:\n\n* STEP 1: Participants must have systemic AL amyloidosis which is biopsy proven and includes histologically-confirmed by positive Congo red stain with green birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence). If there is question regarding diagnosis, consult study chairs prior to registration\n* STEP 1: Participants must have measurable disease within 28 days prior to treatment if initiated prior to registration or within 28 days of registration as defined by at least one of the following:\n\n  * Positive monoclonal serum immunofixation electrophoresis\n  * Positive monoclonal urine immunofixation electrophoresis\n  * Monoclonal plasma cells in bone marrow In addition, participants must also have a difference between the involved and uninvolved free light chain (dFLC) \\>= 2 mg\u002FdL\n* STEP 1: Participants may receive up to one cycle (or 28 days) of therapy prior to enrollment. If a patient receives \\>= 75% of 1 cycle of protocol identical Dara-VCD, this will be considered 1 cycle of protocol induction. Any patient who receives less than 75% of 1 cycle of Dara-VCD or non-protocol therapy will still be eligible but will be treated per protocol. If protocol identical therapy is initiated prior to enrollment, this treatment is not continued but rather treatment is dictated per protocol\n* STEP 1: Participants may be receiving chronic corticosteroids if they are being given for disorders other than AL amyloidosis or myeloma\n* STEP 1: Participant must be \\>= 18 years old\n* STEP 1: Participant must have Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)\n* STEP 1: Participant must have a complete medical history and physical exam within 28 DAYS prior to registration\n* STEP 1: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation\n* STEP 1: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg\u002Fm\\^2 or 140 mg\u002Fm\\^2 (200 mg\u002Fm\\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:\n\n  * Participant must have a supine systolic blood pressure (BP) \\>= 90 mmHg (at registration step-1, this may by supported by midodrine\n  * Participant must have non-severe cardiac AL (meeting all the below criteria) as defined by:\n\n    * N-terminal proB-type natriuretic peptide (NT proBNP) \\\u003C 5000 (if no NTproBNP, brain natriuretic peptide \\[BNP\\] must be available and \\\u003C 400)\n    * Troponin T (TnT) \\\u003C 0.06. If not available, one of the following two criteria must be met:\n\n      * High sensitivity troponin (hsTnT) T \\\u003C 75 or troponin I \\\u003C 0.1ng\u002FdL\n    * New York Heart Association (NYHA) I or II\n    * Cardiac ejection fraction (EF) \\>= 40%\n* STEP 1: Hemoglobin \\>= 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 day prior to registration (within 28 days prior to registration) (NOTE: Growth factor support granulocyte colony-stimulating factor \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 1: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (within 28 days prior to registration)\n* STEP 1: Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 1: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 1: Participants must have a serum creatinine =\\\u003C the institutional (I)ULN OR measured OR calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to registration\n* STEP 1: If peripheral neuropathy is present at diagnosis, participants must be grade 2 (moderate symptoms; limiting instrumental activity of daily living \\[ADL\\]) or less\n* STEP 1: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* STEP 1: Participants must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n* STEP 1: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* STEP 1: Participants must not have concurrent multiple myeloma as defined by the presence of lytic bone disease, plasmacytomas, \\>= 60% plasma cells in the bone marrow, or hypercalcemia. Participants will not be excluded solely based on the presence of plasma cells \\> 10% in the bone marrow unless the plasma cell percentage exceeds \\>60%\n* STEP 1: Participants must not have known allergies to any of the study drugs\n* STEP 1: Participants must not have had a major surgery within 14 days prior to registration and be fully recovered from surgery completed within 14 days prior to registration\n* STEP 1: Participants must not have a known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal\n* STEP 1: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* STEP 1: Participants must not have either moderate or severe persistent asthma within the past 2 years), or currently have uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)\n* STEP 1: Participants must not have uncontrolled diabetes within 28 days prior to registration\n* STEP 1: Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration. Participants must have a supine systolic BP of \\>= 90 mmHg\n* STEP 1: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* STEP 1: Participants must not have received vaccination with live attenuated vaccines within 28 days prior to Registration to Step 1\n* STEP 1: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* STEP 1: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* STEP 1: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwestern Oncology group (SWOG) Specimen Tracking System\n* STEP 1: Participants must agree to have blood, bone marrow core biopsy and aspirate, and fat pad biopsy specimens submitted for minimal residual disease assessment and future exploratory studies\n* STEP 1: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life\n* STEP 2: Participants must have met all eligibility criteria for Step-1 registration\n* STEP 2: Participants must have achieved at least a partial response\n* STEP 2: Participants must continue receiving at least one of study drugs (bortezomib, cyclophosphamide, or daratumumab and hyaluronidase-fihj) if another study drug (daratumumab and hyaluronidase-fihj, cyclophosphamide, or bortezomib) has been discontinued due to adverse events. Note: daratumumab and hyaluronidase-fihj cannot be permanently discontinued\n* STEP 2: Participants must have completed induction therapy\n* STEP 2: Participants must be registered to Step 2 within 42 days of cycle 3, day 28 of induction therapy\n* STEP 2: Participants must plan to initiate their assigned consolidation therapy within 8 weeks after randomization\n* STEP 2: Participants must not have experienced a MOD-PFS event\n* STEP 2: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)\n* STEP 2: Participant must have a complete medical history and physical exam within 28 days prior to registration\n* STEP 2: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation\n* STEP 2: Participants randomized to Arm 2 must be willing and able to return to a participating treatment center for their assigned treatment after transplant. Note that participants need not to have a direct relationship with the transplant center in order to register\n* STEP 2: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg\u002Fm\\^2 or 140 mg\u002Fm\\^2 (200 mg\u002Fm\\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:\n\n  * Patient must have a supine systolic BP \\>= 90 mmHg (at registration step-1, this may not by supported by midodrine)\n  * Patient must have non-severe cardiac AL as defined by:\n\n    * NT proBNP \\\u003C5000 (if no NTproBNP, BNP must be available and \\\u003C 400 pg\u002FmL) (within 14 days prior to registration step-2)\n    * TnT \\\u003C 0.06. If not available, one of the following two criteria must be met (within 14 days prior to registration step-2)\n\n      * hsTnT \\\u003C75 or troponin I \\\u003C 0.1ng\u002FdL\n    * NYHA I or II (within 14 days prior to registration step-2)\n    * Cardiac EF \\>= 40% (within 14 days prior to registration step-2)\n* STEP 2: Hemoglobin \\> 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Total bilirubin =\\\u003C 1.5 times the institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 2: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: AST\u002FALT =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: Participants must have a serum creatinine =\\\u003C the IULN OR calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* STEP 2: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* STEP 2: Participants randomized to the ASCT arm must be able to have at least 2.0 x 10\\^6 CD34 cells\u002Fkg collected\n* STEP 2: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life\n* STEP 3: Participants must have met all eligibility criteria for Step-1 and Step-2 registration\n* STEP 3: Participants must not have had daratumumab and hyaluronidase-fihj permanently discontinued during induction or consolidation\n* STEP 3: Participants must have completed induction and consolidation therapy\n* STEP 3: Participants must be registered to Step 3 within the following time frames:\n\n  * If randomized to Arm 1 Dara-VCD consolidation: within 28 days of completion of 3 cycles of consolidation therapy\n  * If randomized to Arm 2 high dose chemotherapy and autologous stem cell transplantation: within 180 days following initiation of stem cell transplantation\n* STEP 3: Participants must not have experienced a MOD-PFS event\n* STEP 3: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 is allowed if secondary to neuropathy)\n* STEP 3: Participants must have a complete medical history and physical exam within 28 DAYS prior to registration\n* STEP 3: Hemoglobin \\> 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 3: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (within 28 days prior to registration)\n* STEP 3: AST\u002FALT =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 3: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 3: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\nFor participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":334,"type":21},338,[55],"This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.",[338],"AL Amyloidosis",{"date":300,"type":37},{"date":341,"type":37},"2024-07-01",{"date":343,"type":21},"2030-10-29",{"name":43,"class":44},117,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":5},"100488630","phase-3-comparing-cooling-andor-compression-approaches-of-limbs-for-prevention-of-chemotherapy-induced-peripheral-neuropathy-100488630","NCT05642611","Comparing Cooling and\u002For Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy","Ice Compress: Randomized Trial of Limb Cryocompression Versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuropathy","ICE COMPRESS","Inclusion Criteria:\n\n* Participants must have a diagnosis of a solid tumor malignancy.\n* Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.\n\n  * Weekly paclitaxel x 12 consecutive weeks\n  * Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)\n  * Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery\n  * Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is allowed. Pembrolizumab (or other immune checkpoint inhibitors), trastuzumab and\u002For pertuzumab, or bevacizumab are allowed.\n* Participant must be \\>= 18 years old.\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.\n* Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.\n* Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\nFor participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations.\n\nExclusion Criteria:\n\n* Participants must not have a history of skin or limb metastases.\n* Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).\n* Participants must not have pre-existing clinical peripheral neuropathy from any cause.\n* Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.\n* Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.",{"count":355,"type":21},777,[55],"This phase III trial compares the effect of 3 study approaches in preventing chemotherapy-induced peripheral neuropathy: 1) cryocompression, 2) continuous compression, and 3) low cyclic compression. Taxane chemotherapy drugs, such as paclitaxel or docetaxel, can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling, or pain in the arms and legs. The 3 study approaches will use a device, called the Paxman Limb Cryocompression System, made of wraps that cool and\u002For compress the arms and legs. This study may help researchers determine if any of the study approaches are able to prevent taxane chemotherapy from causing peripheral neuropathy.",[359],"Malignant Solid Neoplasm",{"date":300,"type":37},{"date":362,"type":37},"2023-06-06",{"date":364,"type":21},"2031-08-30",{"name":43,"class":44},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":375,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100429397","immune-checkpoint-inhibitor-toxicity-risk-prediction-in-solid-tumors-100429397","NCT04871542","Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors","Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study","Inclusion Criteria:\n\n* Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial\n* Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration\n* Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE\n* Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration\n* Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:\n\n  * =\\\u003C Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)\n  * =\\\u003C Grade 2 for neuropathy and\u002For alopecia\n  * Grade 3 or less for any hematologic side effects\n* Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration\n* Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer\n* Participants must be at least 18 years of age\n* Participants must complete their history and physical examination within 28 days prior to registration\n* Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments\n* Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments\n* Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration\n* Participants must be willing to participate in PRO data collection\n\n  * Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)\n* Participants must be offered the opportunity to participate in the optional specimen banking\n* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines",{"count":374,"type":21},2062,"OBSERVATIONAL","This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.",[359],{"date":279,"type":37},{"date":380,"type":37},"2021-09-13",{"date":382,"type":21},"2028-03-14",{"name":43,"class":44},849,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":392,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":4},"100614372","testing-an-educational-program-to-improve-goals-of-care-conversations-between-patients-and-their-care-teams-100614372","NCT07278739","Testing an Educational Program to Improve Goals of Care Conversations Between Patients and Their Care Teams","A Randomized Controlled Trial of an Intervention Called \"Algorithm-Enabled Patients Activated in Cancer Care Through Teams\" (A-PACT) to Improve Goals of Care Communication for People With Cancer","Inclusion Criteria:\n\n* Participants must have a diagnosis of a solid tumor malignancy of any stage\n* Participants must be identified as high risk, defined as having 6 month mortality estimate from machine learning (ML) algorithm \\>= 20%\n* Participants must not be receiving or have pre-existing plans to enter hospice care at the time of study registration\n* Participant must be actively receiving or planning to receive systemic anti-cancer therapy (defined as any oral, injection, or intravenous therapy against cancer) within 3 months after registration\n\n  * NOTE: This includes chemotherapy (conventional or cytotoxic chemotherapy), hormone therapy, targeted therapy, and immunotherapy\n  * NOTE: Participants are allowed to be co-enrolled on other clinical trials including trials using investigational agents\n* Participants must be \\>= 18 years of age at the time of study enrollment\n* Participants who can complete Patient Reported Outcome (PRO) questionnaires in English or Spanish must be willing to 1) complete PROs at all scheduled assessments; and 2) complete the pre-registration (baseline) PRO forms within 14 days prior to registration\n* Participants must be able to provide a valid telephone number for the purpose of being contacted by the lay health worker\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Patient and clinician participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative NOTE: For this study, in the OPEN registration, clinician participants will be listed as their own treating investigator. However, clinician participants must not consent themselves or sign their own eligibility criteria forms",true,{"count":394,"type":21},1020,[396],"NA","This clinical trial evaluates an educational program called Algorithm-Enabled Patients Activated in Cancer Care Through Teams (A-PACT) for reducing unplanned hospital visits and improving goals of care conversations with providers among patients with solid cancers. A-PACT is an educational program where lay health workers (educators) help patients talk with their health care team about issues that matter most to them (goals of care). During A-PACT sessions, patients receive assistance in formulating health care and end of life care preferences, assistance in completing advance directives, guidance on how to engage in these conversations with family members, friends, and clinical teams, and encouragement to discuss these topics with their clinical team. A-PACT may reduce unplanned hospital visits and improve goals of care communication with providers among patients with solid cancers.",[359],"2026-04-13",{"date":401,"type":37},"2026-04-16",{"date":403,"type":21},"2026-05-03",{"date":405,"type":21},"2032-07-21",{"name":43,"class":44},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":419,"conditions":420,"keywords":423,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":4},"100631248","phase-4-comparing-momelotinib-and-ruxolitinib-in-people-with-untreated-myelofibrosis-and-low-blood-cell-counts-100631248","NCT07498205","Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts","A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis","APEX-MF","Registration Step 1: Randomization\n\nInclusion Criteria:\n\n* Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.\n* Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.\n* Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.\n* Participants must have blasts \\\u003C10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be \\\u003C10% as well.\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must be ≥ 18 years old at the time of registration.\n* Participants must have Zubrod\u002FECOG Performance Status of 0-2.\n* Participants must have a complete medical history and physical exam within 28 days prior to Step 1 registration.\n* Participants must meet hematologic parameters within 28 days prior to Step 1 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 1 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.\n* Participants must be able to take orally administered medication and comply with the oral regimen.\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at Step 1 registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to Step 1 registration.\n* Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.\n* Participants must be offered the opportunity to participate in specimen banking.\n* Participants who can complete PRO and QOL questionnaires in English or Spanish languages must agree to participate in the patient-reported outcomes and quality of life questionnaires.\n* Participants or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and WCG IRB regulations.\n\nExclusion Criteria:\n\n* Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.\n* Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.\n* Participants must not have received prior JAK or ACVR1 inhibitor treatment.\n* Participants must not have received investigational therapy within 14 days prior to Step 1 registration.\n* Participants must not have had a prior splenectomy.\n* Participants must not have had splenic irradiation within 90 days prior to Step 1 registration.\n* Participants must not have received prior chemotherapy for their MF (e.g., hypomethylating agent, hypomethylating agent + venetoclax).\n* Participants must not have had major surgery within 21 days prior to Step 1 registration.\n* Participants must not have received a live vaccine within 14 days prior to Step 1 registration.\n* Participants must not have grade 2 or higher peripheral neuropathy.\n* Participants must not have clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; or unstable angina pectoris. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n* Participants must not have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants must not have history of stroke, reversible ischemic neurologic deficit, or transient ischemic attack within 90 days prior to Step 1 registration.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Participants with curatively treated basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical cancer and\u002For in situ breast cancer may be enrolled.\n* Participants must not have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator.\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n\nRegistration Step 2: Optional Crossover for All Participants after Week 24 Assessment\n\nInclusion Criteria:\n\n* Participants must have met one or more of the following criteria on Registration Step 1:\n\n  1. Spleen volume decrease \\\u003C10% or spleen volume increase of any volume from baseline MRI (or CT) in response to initial treatment (momelotinib or ruxolitinib) from baseline MRI (or CT) at week 24.\n  2. ≥ 3 units of RBC transfusions during any rolling 8-week period starting at or after week 16 preceding Step 2 registration OR hemoglobin \\\u003C 8 g\u002FdL on two consecutive measurements at least 1 week apart during any rolling 8-week period starting at or after week 16 preceding Step 2 registration.\n  3. Unacceptable toxicities attributed to initial treatment (momelotinib or ruxolitinib) of grade ≥ 3 (or grade \\\u003C 3 if determined clinically significant by treating physician) as determined by treating physician.\n  4. Unable to maintain total daily ruxolitinib dose ≥ 20 mg due to cytopenias or intolerance (crossover to momelotinib only).\n* Participants must be able to safely receive the crossover drug (either momelotinib or ruxolitinib) in the opinion of the treating investigator.\n* Participants must have adequate organ and marrow function within 14 days prior to Step 2 registration.\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to Step 2 registration. For creatinine clearance formula see the tools on the CRA Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx.",{"count":416,"type":21},268,[418],"PHASE4","The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.",[421,422],"Myelofibrosis","Myelofibrosis (MF)",[421,424,425],"momelotinib","ruxolitinib","2026-04-03",{"date":428,"type":37},"2026-04-09",{"date":430,"type":21},"2026-08-08",{"date":432,"type":21},"2031-08-08",{"name":43,"class":44},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100341312","s1703-serum-tumor-marker-directed-disease-monitoring-in-patients-with-hormone-receptor-positive-her2-negative-metastatic-breast-cancer-100341312","NCT03723928","S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer","Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n* Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \\[ER+\\] and\u002For progesterone receptor positive \\[PR+\\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +\u002F- targeted therapy +\u002F- chemotherapy).\n\n  * NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and\u002For recurrent breast cancer from an earlier stage that is now metastatic\n* Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease\n* Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +\u002F-14 days of initiation of first-line systemic treatment for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (at least one of these must be tested)\n  * At least one of the tested STMs must have been \\>= 1.5 x the institutional upper limit of normal at this time.\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.\n\n  * Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion\n* Patients must be willing to obtain disease monitoring (imaging and\u002For serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.\n* Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels\n* Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response\n* Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule\n* Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments\n* Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging\n* Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:\n\n  * Adequately treated basal (or squamous cell) skin cancer\n  * Any cancer from which the patient has been disease free for five years\n  * Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins\n* Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.\n* Patients must have decision making capacity and be able to provide informed consent\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2 RANDOMIZATION\n* Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \\>= 10% at this time.\n* Patients must not have known progression since registration to step 1\n* Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization\n* Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)",{"count":442,"type":21},739,[396],"This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.",[183,446,447,448,449,450],"Estrogen Receptor Positive","HER2\u002FNeu Negative","Progesterone Receptor Positive","Prognostic Stage IV Breast Cancer AJCC v8","Elevated CA15-3 or CEA or CA27-29","2026-04-01",{"date":453,"type":37},"2026-04-02",{"date":455,"type":37},"2018-09-17",{"date":457,"type":21},"2036-12-01",{"name":43,"class":44},723,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":392,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100594394","phase-3-evaluating-whether-an-educational-website-called-current-together-after-cancer-ctac-improves-follow-up-care-for-colorectal-cancer-survivors-100594394","NCT07018869","Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors","A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention Called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance","Inclusion Criteria:\n\n* PATIENTS:\n* Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below\n* Patient participants must have an adult in their life who supports them in their colorectal cancer journey who they might be willing to invite to join them in viewing an educational website. This is determined via the question: \"Do you have an adult in your life, such as a spouse\u002Fpartner, family member or friend, who supports you with your colorectal cancer journey and may be willing to view a website with you? When we say, \"supports you in your colorectal cancer journey\", we mean things like, helping you keep and get to medical appointments, talking with you and\u002For your doctors about your cancer, or helping you make decisions about your cancer.\"\n\n  * Those who respond \"no\" to the question above will be told that \"Because this study is for patients and a supporter to view the website together, you are not eligible for this study, but there may be other studies you are eligible for in the future\".\n  * NOTE: The above question will be used to define \"supporter\" for purposes of this study. Examples of supporters include a spouse, partner, sibling, adult child, another family member, or friend.\n  * NOTE: The supporter does not have to agree to participate in the study in order for the patient to be eligible for this study. Justification for requiring the enrolled patient to have a supporter (whether the supporter is invited or participates) is based on the study's underlying conceptual framework\n* Patient participants must not have recurrent or metastatic (stage IV) colorectal cancer\n* Patient participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the efficacy assessment of this intervention\n* Patient participants must be registered within 90 - 180 days of surgical resection\n* Patient participants must be ≥ 18 years of age at the time of registration\u002Frandomization. The lower cutoff of 18 was determined because the lower age range of patients that may be recruited to Southwest Oncology Group (SWOG) studies is 18\n* Patient participants must have Zubrod performance status of 0-2\n* Patient participants must be able to read English or Spanish since the website for the intervention and control arm are available in English and Spanish\n* Patient participants must: 1) be able to complete Patient Reported Outcome (PRO) questionnaires in English or Spanish, and 2) agree to complete PROs at all scheduled timepoints\n* Patient participants will be encouraged to provide an email address or cell phone number, if possible, for the purpose of being contacted by staff at the University of Michigan who will provide access to the educational website. For those who do not wish to provide or create an email address or a cell phone number, they may still participate with alternate methods\n* Patient participants must not be enrolled or be planning to enroll in a clinical trial of investigational treatment that includes imaging and\u002For laboratory monitoring for the duration of this trial\n\n  * NOTE: Patient participants are allowed to be co-enrolled on other non-treatment clinical trials\n* SUPPORTER PARTICIPANT:\n* Supporter participants must be ≥ 18 years of age at the time of registration\u002Frandomization\n* Supporter participants must be able to read English or Spanish since the educational website is available in English and Spanish\n* Supporter participants must have been identified by the patient as a person who may be willing to join them in reviewing the educational website\n* PATIENT AND SUPPORTER:\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Patient and supporter participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative",{"count":468,"type":21},1057,[55],"This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant). Surveillance care after resection of colorectal cancer is critical to detect potentially curable return of disease (recurrence), yet up to 60% of colorectal cancer survivors fail to receive surveillance. This may be due to a lack of knowledge about the purpose of surveillance care and the risks of cancer recurrence, or a lack of confidence for managing surveillance care. The CTAC intervention is an online education intervention designed to improve patients' knowledge about surveillance and their self-efficacy for managing surveillance, and to promote effective communication with supporters and supporter engagement in patients' surveillance in a way that is aligned with each patient's preferences. By increasing a patient's knowledge, self-efficacy, and satisfaction with their supporter's engagement in their care, the CTAC intervention may increase the number of patients who receive guideline-concordant surveillance care after resection of colorectal cancer.",[472,473],"Colorectal Cancer Stage II","Colorectal Cancer Stage III","2026-03-25",{"date":476,"type":37},"2026-03-31",{"date":478,"type":37},"2025-10-15",{"date":480,"type":21},"2029-06-06",{"name":43,"class":44},384,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100578141","phase-3-lanreotide-versus-placebo-before-surgery-to-prevent-a-surgical-complication-called-a-pancreatic-fistula-100578141","NCT06807437","Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula","A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula","Inclusion Criteria:\n\n* Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential\n* Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration\u002Frandomization date\n* Participants must not have a known history of a prior diagnosis of malabsorption syndrome\n* Participants must not have been treated with any somatostatin analogue within 180 days prior to registration\u002Frandomization\n* Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration\u002Frandomization\n* Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration\u002Frandomization\n* Participants must be ≥ 18 years old\n* Participants must have a complete documented medical history and physical exam within 28 days prior to registration\u002Frandomization\n* Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft -Gault formula within 60 days prior to registration\u002Frandomization\n* Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:\n\n  * Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed\n  * Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels\n  * Bromocriptine: Dose adjustments may be considered to account for absorption changes\n  * Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary\n  * CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure\n* In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy\n\n  * NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible\n* In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation\n* Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase \\[AST\\] \\> 190 U\u002FL or alanine aminotransferase \\[ALT\\] \\> 320 U\u002FL) within 60 days prior to registration\u002Frandomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped)\n* Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study\n* NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":242,"type":21},[55],"This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.",[494,495],"Pancreatic Carcinoma","Pancreatic Neoplasm",{"date":476,"type":37},{"date":498,"type":37},"2025-05-09",{"date":500,"type":21},"2027-11-01",{"name":43,"class":44},118,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":528},"100575195","phase-2-using-biomarker-tests-to-select-and-test-new-personalized-treatments-for-extensive-stage-small-cell-lung-cancer-prism-study-100575195","NCT06769126","Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study","PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)","Inclusion Criteria:\n\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a history of limited stage small cell lung cancer\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must meet 1 of the following criteria prior to step 1:\n\n  * Treatment naïve and planning to receive frontline induction treatment with platinum plus etoposide in combination with durvalumab, OR,\n  * Have initiated frontline induction therapy and completed at least 1 (≥ 1) cycle and at most 3 (≤ 3) cycles of platinum and etoposide. At most 2 (≤ 2) of these cycles could have been given without durvalumab\n\n    * NOTE: Participants must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any anti PD-1 or anti PD-L1 (including durvalumab \\[MEDI4736\\]) treatment for SCLC prior to starting frontline induction treatment for ES-SCLC\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received anti PD-1 or anti PD-L1 other than durvalumab (MEDI4736) as part of frontline induction treatment for ES-SCLC. Participants must have not received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for SCLC treatment while receiving treatment on this study\n\n  * NOTE: If participant has bone metastases, bisphosphonates are allowed\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be ≥ 18 years old at the time of step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be able to safely receive the frontline induction treatment with platinum plus etoposide in combination with durvalumab, per the current Food and Drug Administration (FDA)-approved package insert(s), institutional guidelines, and the treating investigator's discretion\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator within 28 days prior to step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have had an allogenic organ transplantation\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have adequate tumor tissue available from SCLC and agree to have these tissue specimens submitted. Participants must agree to have any leftover tissue (tissue that remains after subtype and biomarker testing) retained for the use of future correlative studies.\n\n  * NOTE: After a participant has been registered to step 1 registration, the tissue must be submitted to BostonGene. Sites will receive a notification from the Southwest Oncology Group (SWOG) Statistics and Data Management Center within 19 days after tissue submission. Patients must not be registered to step 2 prior to receiving notification of cohort assignment\n  * NOTE: A histologic review will be performed to confirm adequate cellularity for the testing. If inadequate cellularity, additional archival unstained slides from the same participant may be submitted if it does not exceed the window of starting maintenance therapy\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) of the participant's SLFN11 testing results and have been determined to have subtype A, N, I, or P: confirmed by BostonGene and assigned to a cohort\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants may have measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and must have their disease assessed by CT of chest\u002Fabdomen\u002Fpelvis (with contrast unless contraindicated) within 28 days prior to step 2 for measurable disease or within 42 days prior to step 2 for non-measurable disease. All known sites of disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1). Any lesions assessed using a non-diagnostic PET\u002FCT of chest\u002Fabdomen\u002Fpelvis will be considered non-measurable lesions\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to step 2 randomization. Participant must not have leptomeningeal disease, spinal cord compression, or symptomatic brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to step 2 randomization\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with untreated brain metastases must be asymptomatic and stable off steroids prior to step 2 randomization.\n\n  * NOTE: Exceptions to corticosteroid criterion are: (1) intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), (2) systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent, or (3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Premedication with steroids for chemotherapy is acceptable\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced disease progression in the opinion of treating investigator during induction treatment and prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have completed frontline induction therapy. Induction therapy must have included 4-6 cycles of platinum plus etoposide and 4 cycles of durvalumab (MEDI4736); at most 2 (≤ 2) cycles of platinum plus etoposide may have been given without durvalumab (MEDI4736). Durvalumab (MEDI4736) must have been given in combination with platinum plus etoposide\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants who received consolidation thoracic radiation therapy must have completed all radiation therapy at least 14 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants not receiving consolidation thoracic radiation, step 2 registration must occur at least 3 weeks but not more than 6 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \\[MEDI4736\\])\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants receiving consolidation thoracic radiation after induction therapy, step 2 registration must occur at least 3 weeks but no more than 8 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \\[MEDI4736\\])\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received atezolizumab, pembrolizumab, or nivolumab as part of their frontline induction treatment. Participants must not have received prophylactic cranial irradiation (PCI)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a complete medical history and physical within 28 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have body weight \\> 30 kg\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Hemoglobin \\> 9.0 g\u002FdL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) ≤ 5 × institutional ULN (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have creatinine ≤ 1.5x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 45 mL\u002Fmin using the following Cockcroft-Gault Formula For creatinine clearance formula see the tools on the Cancer Research and Biostatistics (CRA) Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to step 2 registration\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured or currently be receiving treatment for HVC. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-mediated adverse event (irAE) (except asymptomatic nonbullous\u002Fnonexfoliative rash) or any unresolved grade 2 irAE, nor have experienced a toxicity that led to permanent discontinuation of prior durvalumab (MEDI4736). Toxicity of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received a live or live attenuated vaccine within 30 days prior to step 2. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking",{"count":511,"type":21},900,[24],"This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.",[515,516,517,518,519],"Extensive Stage Lung Small Cell Carcinoma","Lung Small Cell Carcinoma, A Subtype","Lung Small Cell Carcinoma, I Subtype","Lung Small Cell Carcinoma, N Subtype","Lung Small Cell Carcinoma, P Subtype","2026-03-24",{"date":522,"type":37},"2026-03-30",{"date":524,"type":37},"2025-11-06",{"date":526,"type":21},"2029-12-31",{"name":43,"class":44},148,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100623201","phase-2-treatment-for-advanced-non-small-cell-lung-cancer-with-actionable-genomic-alterations-after-targeted-treatment-and-chemotherapy-an-expanded-lung-map-treatment-trial-100623201","NCT07393555","Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)","A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)","Inclusion Criteria:\n\n* Participants must have been assigned to S1900N by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900N is determined by submission of documentation of NSCLC harboring an actionable genomic alteration (AGA) in the LUNGMAP protocol. AGA is defined in this protocol as an activating driver alteration with an approved targeted therapy for lung cancer in one of the following genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1.\n* Participants must have measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)\u002FCT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to randomization.\n* Participants must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to randomization.\n* Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (≤ 10 mg daily prednisone or equivalent) prior to randomization. Participants with spinal cord compression or brain metastases that require local treatment must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and\u002For 14 days following whole brain radiation, and prior to randomization.\n* Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to randomization and must not be planning to receive the CNS-specific treatment while on study.\n* Participants must have progressed (in the opinion of the treating physician) during or following the most recent line of systemic therapy.\n* Participants must have previously received an appropriate targeted therapy for the lung cancer AGA (ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1).\n* Participants must have previously received platinum-based chemotherapy for stage IV or recurrent disease.\n* Participants must have received no more than (\\\u003C=) 3 lines of prior cytotoxic therapy (including chemotherapy, antibody-drug conjugates) for NSCLC.\n* Participants must not have received prior TROP2-targeted antibody-drug conjugate or a systemic therapy containing sacituzumab govitecan\u002FSN-38.\n* Participants must not have received prior anti-PD-1 or anti-PD-L1 antibody therapy.\n* Participants must not have received any systemic lung cancer therapy (except orally administered drugs) within 21 days prior to randomization. Orally administered lung cancer therapies must not have been administered within 10 days prior to randomization.\n* Participants must have completed any prior radiation therapy within 7 days prior to randomization.\n* Participants must have recovered (≤ Grade 1) from any side effects of prior therapy (except for alopecia) prior to randomization.\n* Participants must not be planning to receive any concurrent systemic therapy (e.g. chemotherapy, immunotherapy, targeted therapy etc) for lung cancer treatment while receiving treatment on this study.\n* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to randomization.\n* Participants must have a complete medical history and physical exam within 28 days prior to randomization.\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Hemoglobin \\>= 10.0 g\u002FdL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to randomization). Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN\n* Participants must have calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to randomization.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.\n* Participants must not have experienced an arterial or venous thrombotic event or hemoptysis within 28 days prior to randomization.\n* Participants must not be planning to receive warfarin (or other coumadin derivatives) while receiving treatment on this study.\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization.\n* Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)\n* Participants must be offered the opportunity to participate in specimen banking",{"count":345,"type":21},[24],"This phase II Expanded Lung-MAP treatment trial compares how well sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan in combination with ivonescimab works in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or is stage IV and has a change in at least 1 of these genes: ALK, EGFR, HER2 (ERBB2), MET, NTRK, RET, and ROS1. This type of gene change is called an actionable genomic alteration (AGA), which means certain treatments can target the change to fight the cancer. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a toxic drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them. Ivonescimab is a bispecific antibody that can bind to two different antigens at the same time. It binds to programmed cell death protein 1 (PD1), a protein found on the surface of T cells (a type of white blood cell) and vascular endothelial growth factor (VEGF), a protein found on the surface of tumor cells. Ivonescimab may strengthen the immune system and interfere with the ability of tumor cells to grow and spread. Giving a combination of sacituzumab govitecan and ivonescimab work better than either drug alone, and sacituzumab govitecan alone, ivonescimab alone, or sacituzumab govitecan and ivonescimab together may work better than standard treatments at shrinking NSCLC with an AGA.",[161,162],"2026-01-30",{"date":542,"type":37},"2026-02-06",{"date":544,"type":21},"2026-08-07",{"date":546,"type":21},"2029-11",{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100487938","phase-2-testing-drug-treatments-after-car-t-cell-therapy-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100487938","NCT05633615","Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma","Inclusion Criteria:\n\n* STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal large B-cell lymphoma (PMBCL)\n* STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma\n* STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter \\> 1.5 cm)\n* STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS) lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must be asymptomatic from their CNS disease\n* STEP 1: REGISTRATION: Participants must be registered for step 1 after they have signed institutional consent for CAR T-cell leukapheresis but prior to the start of lymphodepleting (LD) chemotherapy for commercial CAR T-cell product\n* STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct.\n\n  * Participants must qualify for commercially approved CD19 CAR T-cell therapy per FDA package insert.\n  * If the CAR T-cell product does not meet parameters to be given as an FDA approved product (i.e. does not meet specification criteria mandated by FDA and is infused under an expanded access protocol \\[EAP\\] or single participant investigational new drug \\[IND\\]) the participant will be taken off of study and no longer be eligible for step 2 randomization\n* STEP 1: REGISTRATION: Participants are permitted to receive or have received 'bridging therapy' after CAR T-cell leukapheresis. However, participants must not receive polatuzumab vedotin, and\u002For mosunetuzumab as part of bridging therapy.\n\n  * Bridging therapy is defined as lymphoma directed therapy administered between leukapheresis and the start of LD chemotherapy. This includes cytotoxic chemotherapy (e.g.: bendamustine and rituximab \\[BR\\], rituximab, gemcitabine and oxaliplatin \\[R-gem\u002Fox\\]), radiation, corticosteroids, as well as novel therapies such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.: lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab, tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.\n  * If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they will ineligible to continue on step 1 registration portion of the study and be ineligible for step 2 randomization\n* STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days prior to the start of LD chemotherapy.\n\n  * All pre-CAR T-cell therapy disease must be assessed and documented on the baseline\u002Fpre-registration tumor assessment form.\n  * If receiving bridging therapy, participants must have a PET-CT scan upon completion of all planned bridging therapy. If the PET-CT scan after completion of bridging therapy is consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.\n  * Participants are permitted to receive corticosteroids after leukapheresis without the need to repeat a PET-CT scan. If steroids are used, they must be planned to stop no later than 3 days before CAR -T cell infusion.\n  * If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 1: REGISTRATION: Participants that have previously been treated with polatuzumab vedotin or mosunetuzumab prior to CAR T-cell leukapheresis for either indolent or aggressive NHL are eligible as long as the participant did not have refractory disease or progression\u002Frelapse within 6 months of the last infusion with either agent\n* STEP 1: REGISTRATION: Participants must be planning to receive CAR T-cell infusion no earlier than 2 days and no later than 14 days after completion of the last day of lymphodepleting chemotherapy. Any participant receiving CAR T-cell infusion outside of this window will be ineligible for step 2 randomization\n* STEP 1: REGISTRATION: LD chemotherapy prior to CAR T-cell infusion must be planned to start within 60 days after step 1 registration\n* STEP 1: REGISTRATION: Participants must be \\>= 18 years of age at the time of registration\n* STEP 1: REGISTRATION: Participants must have Zubrod performance score (PS) of 0, 1, or 2\n* STEP 1: REGISTRATION: Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (within 14 days prior to registration)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 1: REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 14 days prior to registration)\n* STEP 1: REGISTRATION: Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 14 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* STEP 1: REGISTRATION: Participants must have an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 60 days prior to registration with a cardiac ejection fraction \\>= 40%.\n\n  * Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.\n  * Participants must not have documented myocardial infarction and percutaneous coronary intervention (PCI) within 6 months prior to registration or myocardial infarction without PCI within 3 months of registration, or unstable angina\n* STEP 1: REGISTRATION: Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 1: REGISTRATION: Participants with hepatitis B virus infection must have undetectable viral load within 14 days prior to registration, be on suppressive therapy and have no evidence of hepatitis B virus (HBV) related hepatic damage\n* STEP 1: REGISTRATION: Participants with hepatitis C infection must have eradication therapy completed, have no evidence of hepatitis C infection (HCV) related damage and have undetectable viral load within 14 days prior to registration\n* STEP 1: REGISTRATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* STEP 1: REGISTRATION: Participants must be offered the opportunity to participate in banking for planned translational medicine and future research. With participant consent, any residuals from the mandatory tissue submission will also be banked for future research.\n\n  * Note: Streck tubes must be ordered in advance. Please allow 5-7 days for shipment of the collection kits\n* STEP 1: REGISTRATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n    * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for step 1 registration\n* STEP 2: RANDOMIZATION: Participant's CAR T-cell product must have met specification parameters to be given as an FDA approved commercial product\n* STEP 2: RANDOMIZATION: Participants must have a PET-CT scan between days 25-40 after CAR T-cell infusion and determined to have a response consistent with stable disease or partial remission by central review compared to most recent pre-LD chemo\u002FCAR T-cell PET-CT scan.\n\n  * Note: Patients with delayed enrollment \\> 21 days after 'day +30' PET-CT scan will necessitate a repeat PET-CT scan if concerning signs or symptoms of lymphoma progression develop.\n  * Note: If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 2: RANDOMIZATION: Eligible participants must be randomized no later than 60 days after CAR -T infusion\n* STEP 2: RANDOMIZATION: Participants must have started LD chemotherapy within 60 days of signing consent for step 1 registration\n* STEP 2: RANDOMIZATION: Participants must have S2114 CAR T-cell therapy form submitted to Southwest Oncology Group (SWOG) prior to step 2 randomization\n* STEP 2: RANDOMIZATION: Participants must have had a PET-CT scan upon completion of all planned bridging therapy if received, with the exception of up to 7 days of corticosteroids. If the PET-CT scan after completion of bridging therapy was consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.\n\n  * If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 2: RANDOMIZATION: Participants must have Zubrod PS of 0, 1, or 2\n* STEP 2: RANDOMIZATION: Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^3\u002FuL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 75 x 10\\^3\u002FuL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\\u003C 2 x institutional ULN (within 7 days prior to step 2 randomization)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 2: RANDOMIZATION: AST and ALT =\\\u003C 3 x institutional ULN (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 7 days prior to step 2 randomization. Estimated creatinine clearance is based on actual body weight (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 2: RANDOMIZATION: Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 2 randomization and on suppressive therapy\n* STEP 2: RANDOMIZATION: Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 2 randomization\n* STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be continuing to receive anti-retroviral therapy and have an undetectable viral load test within 14 days prior to step 2 randomization\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have documented disease progression while on Arm 4 (observation) on this protocol. The follow-up tumor assessment form documenting disease progression must be submitted to SWOG prior to step 3 crossover registration\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must be registered within 28 days of the date of progression\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have imaging that clearly demonstrates progression compared to day +30 PET-CT scan\n\n  * Note: These scans should be performed as standard of care and only performed between scheduled response assessments required for study if symptoms arise that are concerning for progression\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have Zubrod PS of 0, 1, or 2\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): ANC \\>= 1.0 x 10\\^3\u002FuL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Platelets \\>= 75 x 10\\^3\u002FuL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Total bilirubin =\\\u003C 2 x institutional ULN (within 14 days prior to step 3 crossover registration)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): AST and ALT =\\\u003C 3 x institutional ULN\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within days prior to step 3 crossover registration. Estimated creatinine clearance is based on actual body weight (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration and on suppressive therapy\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with known human immunodefici",{"count":556,"type":21},396,[24],"This phase II trial tests whether mosunetuzumab and\u002For polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and\u002For polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.",[560,561,562,563,564,565,566],"Diffuse Large B-Cell Lymphoma","Grade 3b Follicular Lymphoma","Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Transformed Follic Lymph to Diff Large B-Cell Lymphoma","Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma",{"date":568,"type":37},"2026-02-02",{"date":570,"type":37},"2023-06-12",{"date":572,"type":21},"2030-06-30",{"name":43,"class":44},87,""]