[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PrECOG, LLC.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":153},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,60,88,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054047","phase-2-phase-ii-study-of-platinumetoposide-plus-ivonescimab-for-extensive-stage-small-cell-lung-cancer-100054047",false,"NCT07057791","Phase II Study of Platinum\u002FEtoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer","Phase II Dose Optimization Study of Platinum\u002FEtoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer","PrE0510","Selection Criteria:\n\n* Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).\n* No prior systemic therapy for the disease under study (ES-SCLC).\n* Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.\n* Patient must be ≥ 18 years of age.\n* Patient must have an ECOG performance status of 0-1.\n* Patient must have the ability to understand and willingness to sign a written informed consent document.\n* Willing to provide archived tumor tissue (if sufficient tumor tissue available) and blood samples for research.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to registration\u002Frandomization. No blood transfusions or growth factor therapy allowed within 7 days of screening labs.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmicroliter (mcL)\n  * Platelets ˃100,000\u002FmcL\n  * Hemoglobin \\>9.0 gram\u002Fdeciliter (g\u002FdL)\n  * Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x Upper Limit Normal (ULN), and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5x ULN\n  * Serum Creatinine ≤ 2x ULN\n  * Creatinine clearance (CrCl) ≥ 50 milliliter\u002Fminute (mL\u002Fmin)\n  * Urine Protein \\\u003C2+\n  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5x ULN or ≤ 5x ULN for patients with liver metastasis\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with liver metastasis or suspected\u002Fdocumented Gilbert's disease\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 120 days after the last dose of study drug(s).\n* Patients must not have symptomatic central nervous system (CNS) metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n* Patients must not have imaging during the screening period that shows:\n\n  1. Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula .\n  2. Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients must not have major surgical procedures or serious trauma within 28 days prior to randomization or plans for major surgical procedures within 28 days after the first dose.\n* Patients must not have history of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:\n\n  1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  2. Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed).\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed.\n* Patients must not have history of major diseases before randomization, specifically:\n\n  1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association (NYHA) classification ≥ Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).\n  2. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to randomization.\n  3. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to randomization.\n  4. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization.\n* Patients must not have poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Patients must not have prolongation of QTc interval \\>480 msec\n* Patients must not have active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to randomization.\n* Patients must not have severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C).\n* Patients must not have uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.\n* Patients must not have history of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.\n* Patients must not have active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Patients must not have pre-existing peripheral neuropathy ≥ Grade 2 by CTCAE V5.0.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration\u002Frandomization are eligible for this trial.\n* Patient must not have received any live vaccine within 28 days prior to registration\u002Frandomization.\n* Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.\n* Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.\n* Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg\u002Fkg) or ivonescimab 20 mg\u002Fkg in combination with carboplatin and etoposide.\n\nIvonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.\n\nIvonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.\n\nParticipants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.\n\nThe purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.",[27],"Extensive Stage Lung Small Cell Cancer",[29,30,31,32,33],"Extensive Stage Small Cell Lung Cancer","Small Cell Lung Cancer","Ivonescimab","Carboplatin","Etoposide","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-03-30",{"date":42,"type":21},"2030-01",{"name":44,"class":45},"PrECOG, LLC.","OTHER",11,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":25,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":59},"100597384",{"count":20,"type":21},[24],[27],[29,30,31,32,33],"2026-06-25",{"date":55,"type":38},"2026-06-29",{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},10,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100643381","phase-3-tarlatamab-and-durvalumab-vs-durvalumab-alone-for-limited-stage-small-cell-lung-cancer-100643381","NCT07637513","Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer","Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)","PrE0512","* Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC).\n* SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.\n\n  * Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.\n  * Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.\n  * Chemotherapy must consist of a platinum agent (carboplatin or cisplatin) and etoposide.\n  * Definitive radiation may include daily treatment ≥ 60 gray (Gy) or twice-daily treatments 45 Gy or other biologically equivalent regimens given concurrently with chemotherapy.\n  * For early LS-SCLC (e.g., T1-2, N0, M0) without lymph node involvement, treatment with stereotactic ablative radiotherapy (SABR\u002FSBRT) and chemotherapy is allowed.\n  * Prophylactic cranial radiation (PCI) is permitted but not required. If PCI is administered, 7 day wash-out period is required before start of study treatment.\n\n    * PCI consists of whole brain radiation therapy delivered in the absence of brain metastases. Hippocampal-sparing whole brain plans are considered PCI.\n  * Patient must be able to be randomized and have planned cycle 1 day 1 treatment within 42 days of the last dose of thoracic radiation therapy or end of last cycle of chemotherapy, whichever was given most recently.\n* Completed chemotherapy and radiation with no evidence of progression of disease per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 (i.e., achieved complete response, partial response, or stable disease), including no evidence of metastatic disease on brain MRI, after treatment but prior to randomization.\n* Patient must be ≥ 18 years of age.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patient must have the ability to understand and willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patient must be willing to provide archived tumor tissue (if available) for research.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to randomization (Echocardiogram (ECHO)\u002FMulti-Gated Acquisition (MUGA) ≤ 28 days).\n\n  * Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmicroliter (mcL)\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Platelets ˃100,000\u002FmcL\n  * Prothrombin time (PT)\u002Finternational normalized ratio (INR) ≤ 1.5x upper limit normal (ULN) except for patients on stable dose anticoagulation for 6 weeks prior to randomization.\n  * Activated partial thromboplastin Time (aPTT) ≤ 1.5x ULN except for patients on stable dose anticoagulation for 6 weeks prior to randomization.\n  * Serum Creatinine ≤ 2x ULN\n  * Creatinine clearance(CrCl) ≥ 30 mL\u002Fmin\n  * ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) ≤ 2.5x ULN\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 2x ULN for patients with documented Gilbert's disease\n  * No evidence of human immunodeficiency virus (HIV) within 6 months of randomization.\n  * Hepatitis B virus (HBV) and Hepatitis C virus (HCV) negative within 6 months of randomization.\n  * Pulmonary Function: No oxygen supplementation\n  * Electrocardiogram (ECG) with no findings of acute\u002Fsubacute ischemia and\u002For clinically significant arrythmia\n  * Cardiac Function: Cardiac ejection fraction ≥ 50% and no large or symptomatic pericardial effusion requiring intervention\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive, or father children by using an accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 90 days after the last dose of study drug(s). Also, patient must not expect to breastfeed, donate eggs, or donate sperm during study or for 90 days after the last dose of study drug(s).\n* Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patient must not have had major surgery within 28 days, or minor surgery within 10 days, before randomization.\n* Patient must not have a history of clinically significant interstitial lung disease or active pneumonitis requiring steroid treatment. Patients with grade 1 radiation pneumonitis or fibrosis are permitted to enroll.\n* Patient 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 (NYHA) Functional Classification (NYHA Classification). To be eligible for this trial, patient must be class IIB or better.\n* Patients with history of autoimmune disorders are eligible to enroll only if no disease flares and not requiring any systemic immunosuppressive agents in the past 5 years. Topical or inhaled steroids are permitted. The following are not exclusionary: vitiligo, asthma, endocrine disorders that required only hormone replacement, psoriasis or other skin disorders that do not require systemic treatment, celiac disease controlled by diet alone.\n* Patients with active primary immunodeficiency are not permitted to enroll.\n* Prior history of severe or life-threatening events (Common Terminology Criteria for Adverse Events (CTCAE) V6.0 grade ≥ 3) from any immune-related therapy.\n* Patients with any condition requiring chronic oral corticosteroids is eligible if steroid dose is ≤ 10 mg\u002Fday prednisone equivalent. Physiologic replacement doses for adrenal insufficiency are permitted even if dose exceeds 10 mg\u002Fday. Inhaled corticosteroids and local steroid injections are permitted. All other uses of steroids must be tapered to ≤ 10 mg\u002Fday before randomization.\n* Patients must not have a history of allogeneic solid organ, allogeneic bone marrow or stem cell transplantation.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within for 6 months of before randomization are eligible for this trial.\n* Patient must not have received any live vaccine within 28 days prior to randomization.\n* Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.\n* Any prior therapy with a selective inhibitor of the DLL3 pathway is not permitted.\n* Any prior therapy with immune-mediated therapy including anti-CTLA-4, anti-PD-1, or anti PD-L1 is not permitted.\n* Receiving another anti-cancer therapy is not permitted except for hormonal therapy for breast or prostate cancer, topical therapies for cutaneous malignancies, or superficial treatments for non-muscle invasive bladder cancers.\n* Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.\n* Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.",{"count":69,"type":21},430,[71],"PHASE3","Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.\n\nTarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.\n\nImage testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.\n\nThe purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).",[74],"Limited Stage Small-Cell Lung Cancer",[76,77,78,30],"Tarlatamab","Durvalumab","Consolidation","NOT_YET_RECRUITING","2026-06-04",{"date":82,"type":38},"2026-06-09",{"date":84,"type":21},"2027-01",{"date":86,"type":21},"2038-06",{"name":44,"class":45},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100614872","phase-3-belantamab-mafodotin-or-daratumumab-with-bortezomib-lenalidomide-and-dexamethasone-for-newly-diagnosed-multiple-myeloma-100614872","NCT07285239","Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","Randomized Phase 3 Trial of Belantamab Mafodotin or Daratumumab in Combination With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","PrE1005","Eligibility Criteria:\n\n* Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of any myeloma treatment.\n* Patient must be considered ineligible for autologous stem cell transplantation by the treating physician because of their age (≥ 70 years) or aged 18 - 70 years with the presence of underlying medical conditions likely to have a negative impact on tolerability of high-dose chemotherapy with stem-cell transplantation, making them transplant ineligible, OR transplant-eligible and refusing stem-cell transplantation until first relapse or later.\n* Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization.\n\n  * ≥ 1g\u002FdL monoclonal protein (M-protein) on serum protein electrophoresis\n  * Involved free light chain ≥ 10 mg\u002FdL or ≥ 100 mg\u002FL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\\u003C0.26 or \\>1.65)\n  * ≥ 200 mg\u002F24 hours of monoclonal protein on a 24-hour urine protein electrophoresis\n  * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)\n* Patient must be ≥ 18 years and \\\u003C80 years of age.\n* Patient must have an Eastern Cooperative Group (ECOG) Performance Status (PS) of 0-2 (PS 3 allowed if secondary to pain).\n* Patient must have IMWG Frailty Score \\\u003C2.\n* Patient must have the ability to understand and willingness to sign a written informed consent document.\n* Patient must be willing to provide bone marrow (aspirate and\u002For biopsy) and blood samples for determination of International Myeloma Society (IMS) risk status and for research. Indeterminate patients with missing or unevaluable samples will be excluded.\n* Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there is no residual toxicity related to radiation and blood counts meet the study requirements.\n* Patient must have a Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), and serum Free Light Chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and\u002For aspirate is required within 28 days prior to registration if measurable disease is only present in bone marrow. Otherwise, a bone marrow examination must have been performed within 90 days prior to registration.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 2 weeks prior to registration.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fmicroliter (mcL)\n  * Platelets ˃75,000\u002FmcL\n  * Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with documented Gilbert's disease\n* Patient must agree to register to the mandatory lenalidomide (Revlimid) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the REMS program.\n* Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 3 months after the last dose of protocol treatment.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patient 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 (NYHA) Functional Classification. To be eligible for this trial, patient must be class 2 or better.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients must not have peripheral neuropathy ≥ Grade 2 on clinical examination or Grade 1 with pain at time of registration.\n* Patients must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n* Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.\n* Patients must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.\n* Patients must not have current corneal epithelial disease except mild punctuate keratopathy.\n* Contact lenses must be avoided for participants while they are receiving belantamab mafodotin treatment unless cleared by an eye-care specialist. If cleared for use, bandaged contact lenses are specifically recommended. Contact lens use may be restarted after discontinuation of belantamab mafodotin treatment, provided the eye-care specialist confirms there are no other contraindications.\n* Patients must not have symptomatic amyloidosis or active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma-proliferative disorder, skin changes) at the time of screening.\n* Patients must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol.","79 Years",{"count":98,"type":21},500,[71],"Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.\n\nBelantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.\n\nMinimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.\n\nThe purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and\u002For prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.",[102],"Multiple Myeloma",[104,105,106,107,108,109,110,111,112,113],"Newly Diagnosed High-Risk Multiple Myeloma","Transplant Ineligible Multiple Myeloma","High-Risk Cytogenetic Multiple Myeloma","Belantamab Mafodotin","Daratumumab-Hyaluronidase","Daratumumab","Bortezomib","Lenalidomide","Decadron","Dexamethasone","2026-05-14",{"date":116,"type":38},"2026-05-18",{"date":118,"type":21},"2026-07",{"date":120,"type":21},"2034-06",{"name":44,"class":45},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":131,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100557432","prospective-non-interventional-study-comparing-osimertinib---chemotherapy-for-egfr-mutated-nsclc-patients-100557432","NCT06538038","Prospective Non-Interventional Study Comparing Osimertinib +\u002F- Chemotherapy for EGFR-Mutated NSCLC Patients","Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +\u002F- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients","Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).\n* Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)\u002FInternational Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.\n* Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.\n* Prior chemotherapy and\u002For immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.\n* Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).\n* Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy\u002Fimmunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.\n* Patients that have received prior radiation therapy in any setting for this disease are eligible.\n* Adults age ≥ 18 years.",{"count":130,"type":21},538,"3 Years","OBSERVATIONAL","The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.",[135,136,137,138],"Non Small Cell Lung Cancer","Epidermal Growth Factor Receptor Gene Mutation","Stage III Lung Cancer","Stage IV Lung Cancer",[140,141,32,142,143],"Osimertinib","Cisplatin","Pemetrexed","EGFR Mutated","2026-03-26",{"date":146,"type":38},"2026-03-27",{"date":148,"type":38},"2024-09-17",{"date":150,"type":21},"2029-08",{"name":44,"class":45},146,""]