[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-non-small-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-non-small-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,46,69,88,98,118,141,163,187,238,262,284,306,328,349,369,399,418,438,458,484,501,544,560,584],{"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":45},"100053647","phase-3-testing-the-addition-of-a-type-of-drug-called-immunotherapy-to-the-usual-chemotherapy-treatment-for-non-small-cell-lung-cancer-an-alchemist-treatment-trial-chemo-io-accio-100053647",false,"NCT04267848","Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])","Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)","Inclusion Criteria:\n\n* A female of childbearing potential is a sexually mature female who:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)\n* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)\n* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263\n* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017\n\n  * Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population\n* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery\n* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis\n* No prior allogeneic tissue\u002Fsolid organ transplant\n* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements\n* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 7 days prior to registration is required\n* No patients with a \"currently active\" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible\n* No hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\n* No known hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 gm\u002Fdl\n* Calculated (Calc.) creatinine clearance \\>= 45 mL\u002Fmin\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)","ALL","18 Years",{"count":20,"type":21},1210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, 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. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.",[27,28,29,30,31,32],"Lung Non-Small Cell Carcinoma","Lung Non-Small Cell Squamous Carcinoma","Lung Non-Squamous Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2020-06-16",{"date":41,"type":21},"2027-01-31",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",1151,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":5},"100615487","phase-2-a-study-of-targeted-post-surgery-radiation-therapy-for-non-small-cell-lung-cancer-with-remaining-lymph-node-cancer-after-treatment-100615487","NCT07293247","A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment","Involved-Station, Intensity-Modulated Post-Operative Radiation Therapy (I²-PORT) for Resected Non-Small Cell Lung Cancer With Residual Mediastinal Adenopathy After Neoadjuvant Therapy (ypN2)","* Histopathologic diagnosis of NSCLC, may have mixed or multiple histologies but no small cell component\n* No known EGFR mutation or ALK rearrangement\n* No metastatic disease (M0) per most recent PET\u002FCT and head CT\u002FMRI imaging\n* No disease progression per CT chest (including upper abdomen as per standard practice) with intravenous (IV) contrast (unless IV contrast is contraindicated) or FDG-PET performed post-neoadjuvant therapy ≤ 90 days prior to registration, either before or after surgery\n* No metastatic disease (M0) per head CT\u002FMRI imaging\n* Prior treatment with 2-4 cycles of neoadjuvant systemic therapy with any guideline (National Comprehensive Cancer Network \\[NCCN\\]) concordant regimen\n* Lobectomy or greater oncologic surgical resection within 8 weeks prior to registration\n* Complete (R0) resection showing ypN2 disease\n* No prior radiotherapy to the lungs or mediastinum\n* No treatment with a VEGF inhibitor ≤ 90 days prior to registration or plan to treat with adjuvant systemic therapy including a VEGF inhibitor\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelet count ≥ 50,000\u002Fmm\\^3\n* Calculated (Calc.) creatinine clearance ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 x upper limit of normal (ULN)\n* Not pregnant, because this study involves radiation therapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\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* Cardiac function: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No idiopathic pulmonary fibrosis requiring anti-fibrotic medication: Patients with idiopathic pulmonary fibrosis or inflammatory\u002Finterstitial lung disease compromising pulmonary function or requiring ongoing treatment with nintedanib, pirfenidone, or other anti-fibrotic drug are excluded\n* HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial",{"count":54,"type":21},164,[56],"PHASE2","This phase II trial compares the effect of intensity-modulated post-operative radiation therapy (I²-PORT) followed by standard of care therapy (chemotherapy or immunotherapy) to standard of care therapy alone in treating patients with non-small cell lung cancer (NSCLC) who have remaining lymph node cancer after surgery. Radiation therapy uses high-energy X-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Intensity-modulated radiation therapy is a type of 3-dimensional 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. 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. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding I²-PORT radiation therapy to standard therapy may be more effective than standard therapy alone in reducing the risk of cancer returning in those who have undergone surgery for NSCLC.",[27],"2026-07-01",{"date":61,"type":37},"2026-07-02",{"date":63,"type":21},"2026-07-14",{"date":65,"type":21},"2032-03-01",{"name":67,"class":68},"Alliance for Clinical Trials in Oncology","OTHER",{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100554403","phase-3-immunotherapy-after-surgery-for-people-who-have-no-remaining-cancer-cells-after-standard-treatment-for-early-stage-non-small-cell-lung-cancer-insight-trial-100554403","NCT06498635","Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial","Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)","Inclusion Criteria:\n\n* Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)\n* Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \\[NCCN\\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.\n\n  * Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease\n* Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review\n* Participants must have a PD-L1 status result (e.g. \\[\\\u003C 1% versus \\>= 1% or unknown\\])\n* Participants must not have known EGFR mutations, or ALK gene fusion\n* Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines\n* Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization\n* Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy\n* Participants must not have received post-operative radiation therapy (PORT) for NSCLC\n* Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator\n* Participant must be ≥ 18 years old at time of study entry\n* Participants must have body weight \\> 30 kg\n* Participant must have Zubrod performance status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to randomization\n* Hemoglobin \\> 9.0 g\u002FdL (within 28 days prior to randomization)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1 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 randomization)\n* Aspartate transaminase (AST)\u002Falanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)\n* Participants must have a calculated creatinine clearance ≥ 40 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\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 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 had an organ transplant\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* Participant 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* 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* Participants must not have received a live or live attenuated vaccine within 28 days prior 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 coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree 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* 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":77,"type":21},306,[24],"This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.",[27,30,31,32],{"date":61,"type":37},{"date":83,"type":37},"2025-04-01",{"date":85,"type":21},"2039-07-15",{"name":43,"class":44},266,{"id":89,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":25,"conditions":92,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":96,"locationsCount":97},"100383070",{"count":20,"type":21},[24],[27,28,29,30,31,32],{"date":61,"type":37},{"date":39,"type":37},{"date":41,"type":21},{"name":43,"class":44},1150,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100622815","phase-3-testing-the-impact-of-an-anti-cancer-drug-atezolizumab-after-surgery-to-prevent-early-stage-non-small-cell-lung-cancer-from-returning-aasi-nsclc-trial-100622815","NCT07388524","Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial","Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-TQJS to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)","Inclusion Criteria:\n\n* Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 9th edition\n\n  * Note: Tumors with any histology are allowed including both squamous and non-squamous subtypes, except those containing small-cell morphology. Non-squamous histology includes adenocarcinoma, large cell neuroendocrine, poorly differentiated tumors and adenosquamous, etc\n* Patient must have undergone complete surgical resection with negative margins (complete R0 resection). Surgical resection must be lobectomy or higher, unless the tumor measured no more than 2 cm based on clinical staging, where sub-lobar resection, e.g., wedge or segmentectomy, will be acceptable\n\n  * Note: For patients who underwent sub-lobar resection for clinical tumors size of ≤ 2.0 cm, must have CT chest confirming tumor size within 60 days of surgical resection. Patients who received a lobectomy or higher do not require to fulfill this imaging criteria\n* Patient must have undergone adequate nodal sampling as defined by Commission on Cancer, 2020 Standard. Adequate nodal sampling includes pathological evaluation of at least one (named and\u002For numbered) hilar station (level 10 or higher) and at least three distinct (named and or numbered) mediastinal stations (level 2-9)\n* PD-L1 immunohistochemistry showing tumor proportion score (TPS) ≥ 50%, by an Food and Drug Administration (FDA)-approved assay including but not limited to SP263, SP142, 22C3, 28-8, performed either on surgical specimen or biopsy specimen\n* No EGFR exon 19 deletion (del) or L858R mutation or ALK fusion; molecular testing may have been performed either on surgical specimen or biopsy specimen. Tumors with purely squamous histology are not required to undergo EGFR or ALK gene testing\n* Patient to be registered to A082302 no earlier than 21 days and no later than 77 days from surgical resection\n* Recovered from surgical resection as determined by the treating provider or the investigator\n* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis\n* Patient must NOT have uncontrolled intercurrent illness, including but not limited to serious ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), unstable angina, or unstable arrhythmia\n* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids or history of interstitial lung disease (ILD)\n* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease modifying agents, corticosteroids, or immunomodulatory agents). Replacement therapy (e.g., thyroid for history of autoimmune thyroiditis, insulin for type I or II diabetes, corticosteroids for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* No known hypersensitivity (≥ grade 3) to atezolizumab and\u002For any of its excipients\n* No live vaccine within 30 days prior to registration. Examples include but are not limited to: measles, mumps, rubella, varicella, yellow fever, Bacillus Calmette-Guerin (BCG), typhoid, nasally administered influenza\n* No history of prior allogeneic bone marrow, stem cell, or solid organ transplant\n* Patient has not received continuous systemic treatment with corticosteroids (\\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days prior to registration, with the following exceptions:\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, if \\\u003C 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen or chronic obstructive pulmonary disease \\[COPD\\] exacerbation) is permitted\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Platelet count ≥ 100,000\u002Fmm\\^3\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN), except patients with Gilbert syndrome who can have total bilirubin \\\u003C 3.0 mg\u002Fdl\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x upper limit of normal (ULN)\n* Creatinine clearance ≥ 30 mL\u002Fmin (using standard Cockcroft-Gault formula, unless measured creatinine clearance \\[CrCl\\] is available and meet the specified threshold)\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required\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\n  * HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Patients with no known history of HIV do not require any testing\n* Hepatitis B and hepatitis C: No active hepatitis B (defined as negative for hepatitis B \\[HepB\\] deoxyribonucleic acid \\[DNA\\], and positive for HepB surface antibody) or hepatitis C (defined as hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected) infection. If there is a history of either infection, patient should be negative for active disease, for hepatitis B negative for hepatitis B virus surface antigen (HBsAg), and for hepatitis C - negative for HCV RNA (qualitative). Patients with no known history of chronic hepatitis do not require any testing\n* No active infection requiring systemic therapy\n* Cardiac function: Patients with known history or current symptoms of heart failure, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better",{"count":106,"type":21},336,[24],"This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results. During active surveillance, patients are given certain exams and tests done on a regular schedule. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Atezolizumab and recombinant human hyaluronidase is a formulation of atezolizumab combined with an enzyme called hyaluronidase, which helps increase tissue absorption of the drug. Giving atezolizumab or atezolizumab and recombinant human hyaluronidase after resection may be effective for preventing NSCLC recurrence, and may be a better approach to treating patients with stage I NSCLC than the usual observation approach.",[27],"2026-06-30",{"date":59,"type":37},{"date":113,"type":21},"2027-03-02",{"date":115,"type":21},"2032-09-30",{"name":43,"class":44},3,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":117},"100533408","phase-1-gilteritinib-for-the-treatment-of-alk-nsclc-100533408","NCT06225427","Gilteritinib for the Treatment of ALK NSCLC","Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Stage IV (American Joint Committee on Cancer \\[AJCC\\] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion\n* Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC NOS (not otherwise specified)\n* The presence of an oncogenic ALK fusion established from any Clinical Laboratory Improvement Act (CLIA) certified laboratory\n* The patient must belong to one of the following treatment cohorts.\n\n  * Cohort 1: Prior 1st generation ALK tyrosine kinase inhibitor (TKI) (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002For lorlatinib\n  * Cohort 2: Prior 1st generation ALK TKI (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002For lorlatinib, and platinum-doublet chemotherapy\n  * Cohort 3: Prior 1st generation ALK TK (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002F or lorlatinib, platinum-doublet chemotherapy, and any other number of antineoplastic agents (including immunotherapy, standard or investigational)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 1500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)\n* Measured or calculated creatinine clearance (CrCl) ≥ 50mL\u002Fmin (calculated per Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (per institutional guidelines) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n* Albumin ≥ 2.5g\u002FdL\n* Female subject of childbearing potential should have a negative serum pregnancy test within 21 days of enrollment prior to receiving the first dose of study medication\n* Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the course of the study, through 180 days after the last dose of study medication. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method\n* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 4 months after the last dose of study therapy. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method\n* Ability to swallow pills orally and per investigator's assessment, do not have any significant issues limiting absorption of drug\n* Ability to understand and the willingness to sign a written informed consent\n* Measurable disease per RECIST v1.1 criteria assessed per screening imaging\n* If a cancerous lesion is easily and safely accessible, a pre-treatment biopsy of this lesion is strongly encouraged but NOT required prior to first dose of gilteritinib. Archival or fresh tissue biopsy may be used as long as it was obtained prior to cycle 1 day 1 (C1D1)\n* At least 7 days must have elapsed since last anti-neoplastic TKI, chemotherapy, immunotherapy, or investigational agent prior to the first dose of gilteritinib\n\nExclusion Criteria:\n\n* Received palliative radiation within 7 days of enrollment\n* Received prior therapy with a FLT3 inhibitor\n* Has a concurrent active malignancy receiving interventional therapy unless it is the investigator's opinion that the concurrent active malignancy will NOT significantly impact the survival of the patient (i.e. early stage breast cancer or prostate cancer on hormonal therapy, basal cell carcinoma awaiting Moh's or other surgery and the respective interventional therapy does NOT interact or interfere with gilteritinib.\n* Has known active and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n  * Subjects with previously treated brain metastases may participate provided they are stable (clinically asymptomatic, and ≥ 2 weeks since completion of treatment) and are not using steroids for at least 7 days prior to enrollment. A repeat MRI brain is not necessary to document stability\n  * Patients with carcinomatous meningitis are excluded regardless of clinical stability\n* If a patient is found to have new\u002Fenlarging brain metastases on the screening MRI, the patient may be monitored closely and radiation could be delayed if the patient has no symptoms, there is no vasogenic edema, and there is no evidence of midline shift.\n\n  * If the patient is symptomatic, there is vasogenic edema, and\u002For there is midline shift, the patient will need to undergo treatment for these brain metastases and meet exclusion criteria #4 exception to treated brain metastases prior to enrollment. A new MRI brain is NOT required in this situation\n* Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment\n* Has Child-Pugh class C cirrhosis from any cause\n* Mean triplicate screening electrocardiogram (EKG) corrected QT (QTc) \\> 480 ms. (QTc Framingham will be used for heart rate \\>100 bpm)\n* Grade 3 or 4 NYHA (New York Heart Association) congestive heart failure, unless screening echocardiogram obtained prior to enrollment showed a LVEF (left ventricular ejection fraction) ≥ 45%\n* Surgery within 4 weeks prior to first study dose\n* Requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A\n* Requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the patient\n* Requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor, with the exception of drugs that are considered absolutely essential for the care of the patient\n* Active\u002Funtreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; patients with treated HBV and HCV are allowed as long as they meet the AST\u002FALT and bilirubin criteria\n* Known hypersensitivity to gilteritinib or any of the excipients\n* Active and clinically significant pancreatitis",{"count":126,"type":21},30,[128],"PHASE1","This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.",[27,131],"Stage IV Lung Cancer AJCC v8","2026-06-23",{"date":134,"type":37},"2026-06-26",{"date":136,"type":37},"2024-07-25",{"date":138,"type":21},"2027-05",{"name":140,"class":68},"University of Michigan Rogel Cancer Center",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100591705","exercise-training-for-the-improvement-of-immune-activity-and-treatment-outcomes-during-immunotherapy-for-non-small-cell-lung-cancer-boost-trial-100591705","NCT06983899","Exercise Training for the Improvement of Immune Activity and Treatment Outcomes During Immunotherapy for Non-small Cell Lung Cancer, BOOST Trial","Boosting the Effects of Immunotherapy Through Exercise Training in Patients With Lung Cancer: The BOOST Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically diagnosed with NSCLC.\n* Currently receiving immunotherapy with a minimum of one month of treatment completed.\n* Having a plan to continue immunotherapy for at least 24 weeks (i.e., study intervention period) at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Able to understand and willingness to provide study consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.\n* Having medical conditions clinically unstable or uncontrollable, with medications that are deemed high-risk for exercise participation by the study team in consultation with the treating oncologist, using the electric medical record (EMR) and Physical Activity Readiness Questionnaire (PAR-Q). This includes but is not limited to: recent (\\\u003C 6 months) myocardial infarction, uncontrolled arrhythmias, decompensated heart failure, unstable angina, symptomatic severe aortic stenosis, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes (hemoglobin A1c \\[HbA1c\\] \\> 10% with symptoms), severe chronic obstructive pulmonary disease requiring hospitalization in past 3 months, and bone metastases with imminent fracture risk. These exclusions are based on the American College of Sports Medicine (ACSM)'s Guidelines for Exercise Testing and Prescription and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR)'s Guidelines for Cardiac Rehabilitation Programs for safe exercise in clinical populations.\n* Having a high risk for noncompliance with study procedures, including but not limited to: informed consent, participation in outcome assessments, completion of fasting blood draws, attendance at scheduled sessions, adherence to supervised virtual exercise sessions, and appropriate use of provided monitoring equipment (e.g., heart rate monitor, blood pressure monitor, SpO2 monitor). This determination will be based on a composite assessment of the following factors: history of missed oncology appointments (i.e., three or more uninformed no-shows in the prior six months) and poor responsiveness to study communications (i.e., three or more repeated unreturned calls or emails during the recruitment stage). We will also consider any demonstrated difficulty following instructions during initial scheduling or onboarding, or clinical concern raised by the referring provider. Participants meeting one or more of these criteria likely to impair participation will be considered ineligible.\n* Patients who are non-English speaking that would prevent their participation in the participant survey.",{"count":149,"type":21},100,[151],"NA","This clinical trial studies how well exercise training works in improving immune activity and treatment tolerance and response in patients with non-small cell lung cancer (NSCLC) who are receiving immunotherapy. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. The use of immunotherapy for the treatment of NSCLC has been rapidly increasing. Although immunotherapy have shown great potential in cancer therapy, not all patients benefit from this therapy and resistance to it can occur. This could be due to poor immune activity. It has been shown that exercise can enhance systemic immune activity in various ways. The exercise training used in this study is aerobic interval training. Aerobic interval training increases the heart rate and the body's use of oxygen and alternates short periods of intense aerobic exercise with less intense recovery periods. This may cause biological changes which may improve immune activity and treatment response in patients with NSCLC who are receiving immunotherapy.",[27],"2026-06-22",{"date":132,"type":37},{"date":157,"type":37},"2026-01-28",{"date":159,"type":21},"2028-05-31",{"name":161,"class":68},"Fred Hutchinson Cancer Center",1,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":162},"100588612","phase-2-photoimmunotherapy-with-asp-1929-and-cemiplimab-for-the-treatment-of-refractory-inoperable-and-metastatic-stage-iiib-iv-non-small-cell-lung-cancer-100588612","NCT06943664","Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer","Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Subjects with histologically or cytologically confirmed stage IIIB-IV NSCLC\n* Subjects lacking actionable genetic mutations must have been previously treated with (a) anti-PD-1\u002FPD-L1 therapy; and (b) platinum-based chemotherapy, either as combination or sequentially for metastatic disease and have progressed on or after therapy. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy or who are unable to receive it are eligible to enroll based on progression after anti-PD-1\u002FPD-L1 therapy alone\n* NSCLC with known actionable genomic alteration (e.g., EGFR, ALK, ROS1, BRAF) must have received all approved targeted therapies and have progressed (data capture not necessary for ALK, ROS1, BRAF)\n* Subjects have at least two lesions of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* At least one site of disease accessible to photoimmunotherapy. Thus, the therapeutic 690-nm laser light can be administered via insertion of optical fiber\u002Fs in the target tumor for interstitial photoimmunotherapy (I-PIT), or target tumors can be illuminated with external beam photoimmunotherapy (EB-PIT)\n* Absolute neutrophil count: ≥ 1,000\u002FµL\n* Platelets: ≥ 100,000\u002FµL\n* Total bilirubin: ≤ institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 x institutional ULN\n* Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n* Patient has not received a transfusion within 2 weeks prior to screening\n* Female patients of childbearing potential must have a negative pregnancy test at screening and must be willing to use 2 methods of highly effective birth control while on study or be surgically sterile, or abstain from heterosexual sexual activity for the course of the study through 120 days after the last dose of anti-PD1 treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Male participants must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of anti-PD1 treatment\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedures\n\nExclusion Criteria:\n\n* Has received an investigational agent within 30 days prior to initial treatment or less than 4 half-lives of a previous drug\n* Had a major surgery, (e.g., requiring general anesthesia) within 4 weeks before the first dose of study treatment or, will not have fully recovered from surgery prior to the first dose\n* Patients who received chemotherapy or chemoimmunotherapy within 21 days or those who have not recovered from reversible adverse events prior to the scheduled surgery and interstitial or intraoperative PIT\n* The participants received high dose or curative radiotherapy to the target tumor\u002Fs within 30 days prior to the planned I-PIT or EB-PIT\n* Toxicity related to prior anticancer therapy that has not returned to grade ≤ 1 or baseline levels (except for alopecia, vitiligo, grade ≤ 2 peripheral neuropathy, and endocrinopathies that are stable on hormone replacement, which may be grade 2)\n* History of immune-related adverse events (irAEs) from prior anticancer therapy leading to permanent treatment discontinuation\n* History of solid organ or hematologic stem cell transplantation\n* Prolonged corrected QT interval by Fredericia (QTcF) \\> 470 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (e.g., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate or abnormalities in conduction or morphology of electrocardiogram \\[ECG\\] \\[e.g., complete left bundle branch block, third- or second-degree heart block, PR interval \\> 250 msec\\]). Note: Participants with cardiac pacemakers who are clinically stable are eligible\n* Clinically significant cardiovascular disease, including any of the following within 6 months prior to signature of informed consent:\n\n  * Myocardial infarction, severe or unstable angina, or coronary artery bypass surgery\n  * Clinically significant arrhythmias (e.g., ventricular arrhythmias or atrial fibrillation with uncontrolled heart rate)\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III\u002FIV)\n  * Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event\n  * Myocarditis\n* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* Patients with untreated or symptomatically unstable treated brain metastases or history of leptomeningeal disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management\n* Known history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved hepatitis B (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of hepatitis B virus surface antigen \\[HBsAg\\]) and patients positive for hepatitis C (hepatitis C virus \\[HCV\\]) antibody if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). HIV testing is not required in absence of clinical suspicion of HIV\n* History of, or active autoimmune disorder, requiring systemic steroids or immunosuppressive agents. Exceptions allowed: Patients with autoimmune dermatologic conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo, eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal supplementation\n\n  * Use of immunosuppressant drugs such as steroids, azathioprine, tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment (exception allowed is use of steroids as hormone replacement therapy or as supportive medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)\n* History of significant (≥ grade 3) cetuximab infusion reactions\n* Evidence of interstitial lung disease or current active, noninfectious pneumonitis\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included\n  * Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive ASP-1929\n* Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive the experimental PIT or immunotherapy\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements",{"count":171,"type":21},27,[56],"This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.",[27,175,176,32,177,131],"Metastatic Lung Non-Small Cell Carcinoma","Refractory Lung Non-Small Cell Carcinoma","Stage IIIC Lung Cancer AJCC v8","NOT_YET_RECRUITING","2026-06-18",{"date":154,"type":37},{"date":182,"type":21},"2026-08-15",{"date":184,"type":21},"2028-05-01",{"name":186,"class":68},"Roswell Park Cancer Institute",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":162},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":195,"type":21},50,[56],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[199,200,201,202,203,204,205,206,207,208,209,210,211,27,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Urothelial Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":231,"type":37},"2026-06-09",{"date":233,"type":37},"2024-04-30",{"date":235,"type":21},"2026-12-31",{"name":237,"class":68},"Mayo Clinic",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":162},"100500894","stereotactic-body-radiation-therapy-planning-with-artificial-intelligence-directed-dose-recommendation-for-treatment-of-primary-or-metastatic-lung-tumors-rad-ai-study-100500894","NCT05802186","Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study","A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors","Inclusion Criteria:\n\n* Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.\n* Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.\n* Patients must be age \\>= 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.\n\n  * NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 7 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. People who can impregnate their partners treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study.\n\nExclusion Criteria:\n\n* Patients who have had prior radiotherapy with radiation field overlap.\n* For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.\n* Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities \\>= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).\n* Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.\n\n  * Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT. Concurrent immunotherapy (if not investigational) is permitted. Coronavirus disease 2019 (COVID-19) vaccinations are allowed.\n* Patients with 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. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n\n  * Ongoing or active infection requiring systemic treatment\n  * Unstable angina pectoris\n  * Stage 3 or greater idiopathic pulmonary fibrosis\n  * Cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.",{"count":246,"type":21},70,[151],"This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Even with the high precision of SBRT, disease persistence or reappearance (local recurrence) can still occur, which could be attributed to the radiation dose. AI has been used in other areas of healthcare to automate and improve various aspects of medical science. Because the relationship of dose and local recurrence indicates that dose prescriptions matter, decision support systems to help guide dose based on personalized prediction AI algorithms could better assist providers in prescribing the radiation dose of lung stereotactic body radiation therapy treatment.",[250,27,251,252,30,31],"Lung Carcinoma","Metastatic Malignant Neoplasm in the Lung","Stage I Lung Cancer AJCC v8","2026-05-26",{"date":255,"type":37},"2026-05-29",{"date":257,"type":37},"2023-11-20",{"date":259,"type":21},"2031-08-01",{"name":261,"class":68},"Northwestern University",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":162},"100609578","phase-2-psilocybin-assisted-therapy-for-the-treatment-of-major-depressive-disorder-in-patients-with-non-small-cell-lung-cancer-100609578","NCT07216404","Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer","Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)","Inclusion Criteria:\n\n* Individuals diagnosed with NSCLC, confirmed by pathology report\n* Have a Karnofsky performance status \\>= 60\n* Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical exclusion criteria outlined below\n* Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression \\[GRID-HAMD\\] \\> 16)\n* English-speaking\n* Over the age of 18\n* Have given written informed consent\n* Able to read\n* Be judged by study team clinicians to be at low risk for suicidality, as defined by a score of =\\\u003C 2 on the Columbia- Suicide Severity rating scale (C-SSRS) ideation subscale, 0 on the behavior subscale, and by overall clinical judgment; and\n* Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)\n\nExclusion Criteria:\n\n* GENERAL MEDICAL EXCLUSION CRITERIA\n* Participants who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; participants who are of child-bearing potential and sexually active who are not practicing a highly effective means of birth control (i.e., implants, injectables, combined oral contraceptives, progestin containing intrauterine devices \\[IUDs\\], or vasectomized partner)\n* Participants with partners of child-bearing potential who are sexually active and not practicing a highly effective means of contraception (i.e., condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository)\n* Cardiovascular conditions: Recent history of coronary artery disease or stroke, current uncontrolled angina, uncontrolled hypertension, a clinically significant electrocardiogram (ECG) abnormality as determined by a cardiologist and\u002For medical monitor (e.g., atrial fibrillation), prolonged corrected QT (QTc) interval (i.e., QTc \\> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year\n* Systolic blood pressure (SBP) \\> 139 mm HG; diastolic blood pressure (DBP) \\> 89 mm HG; heart rate (HR) \\> 90 bpm (mean values of the four or more assessments will not exceed 139 mm Hg systolic, 89 mm Hg diastolic, and\u002For 90 beats per minute)\n* Insulin-dependent diabetes\n* Non-insulin dependent diabetes if recent history of symptomatic hypoglycemia\n* Significant central nervous system (CNS) pathology. Some examples include:\n\n  * Unstable primary or secondary (e.g., metastatic) cerebral neoplasm. Stable is defined as treatment within prior 4 weeks or no immediate plans for treatment.\n  * Unstable history of seizures\n  * Cerebral aneurysm - unstable with plans for intervention or close monitoring\n  * Clinical diagnosis of dementia\n  * Clinical diagnosis of delirium\n* In the investigator's opinion, abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at screening may constitute a risk for an individual exposed to psilocybin. This includes platelets below 100,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, and creatine two times above the normal range. This also includes clinically significant abnormal electrolytes or low hemoglobin (below 10 g\u002FL)\n* Any acute condition that would, in the Investigator's judgment, place the subject at significant risk due to safety concerns or compliance with clinical study procedures (e.g., electrolyte imbalance, infection\u002Finflammation, intestinal obstruction, inability to swallow medication, etc.)\n* Under active treatment of an investigational agent in a clinical trial\n* In the judgement of the clinician, patients currently taking psychoactive medication on a regular (e.g., daily) basis (e.g., cannabis, opiates, Ritalin), other than a daily selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or bupropion (\\\u003C 300 mg daily) (Patients will not be instructed to hold prescribed psychoactive medications)\n* In the judgement of the clinician, patients who self-report or urine test positive for psychoactive medications (e.g., illicit opiates, amphetamines, cocaine) may be excluded, for example recent use by self-report but urine test negative may still be enrolled, while participants with impaired mental status will be excluded\n* PSYCHIATRIC EXCLUSION CRITERIA\n* Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I or II disorder\n* Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol or other drug use disorder (excluding caffeine and tobacco)\n* Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition) or bipolar I or II disorder\n* Has a psychiatric condition that precludes the establishment of therapeutic rapport, as evidenced by long-term patterns of unstable relationships, a history of significant stress-related paranoia, and identity disturbances\n* History of a medically significant suicide attempt as determined by the study team and principal investigator (PI)",{"count":270,"type":21},10,[56],"This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.",[27,274],"Unipolar Depression","2026-05-11",{"date":277,"type":37},"2026-05-14",{"date":279,"type":37},"2026-01-01",{"date":281,"type":21},"2027-10-31",{"name":283,"class":68},"Alan Davis",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100517229","phase-2-biologically-guided-radiation-therapy-bgrt-and-stereotactic-body-radiation-therapy-sbrt-to-tyrosine-kinase-inhibitor-in-oligoprogressive-oncogenic-positive-non-small-cell-lung-carcinoma-100517229","NCT06014827","Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma","Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Histologically confirmed advanced non-small cell lung cancer (NSCLC)\n* The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M.\n* Disease progression in the metastatic setting on PET or CT imaging when receiving first line standard\u002Fapproved single agent osimertinib after having had stable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version \\[v\\] 1.1 or PET Response Criteria in Solid Tumors \\[PERCIST\\] v 1.0) for more than 6 months\n* Disease progression must be in the form of 1-5 extracranial sites (any number of metastatic sites at initial diagnosis will qualify). For progression of the primary and oligoprogressive site(s), the primary should be treated with curative\u002Flocal control intent. The primary, if progressing is considered as 1 site. Maximum of 3 lesions per organ (i.e. patient with 4 oligoprogressive sites in the lung would be excluded). Each lesion will be considered as 1 \"site\" so 3 lesions in the lung for example will be considered 3 sites. Patients with prior metastases that have been treated with ablative therapies before their current line of systemic therapy are eligible. Patients with brain metastases can be included but brain metastases must be treated (asymptomatic and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug) prior to enrollment (brain metastases \\[mets\\] will not be counted as a site of progression)\n* Lesion(s) must be amenable to SBRT as determined by the radiation oncologist. If a patient is unable to receive a minimum of 30 Gy in 5 fractions they will not qualify\n* At least one lesion must be amenable to BgRT which includes either a lung or bone metastasis, greater than or equal to 2 cm, which can also receive a minimum of 30 Gy in 5 fractions\n* No prior systemic therapy for advanced disease other than osimertinib\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Patients must be able to swallow and retain oral medications\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy (6 weeks for nitrosoureas or mitomycin C). Exceptions to this exclusion are brain radiation (2 weeks) and osimertinib\n* Strong CYP3A4 inducers\u002F inhibitors within 14 days prior to day 1 of protocol therapy\n* Patients receiving class 1A or class III antiarrhythmic agents within 14 days prior to day 1 of protocol therapy\n* Drugs known to prolong the corrected QT (QTc) interval\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics bacterial, viral, or fungal infections, requiring systemic therapy\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =\\\u003C 6 =Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry. Other malignancies with low probability of recurrence may be allowed with primary investigator (PI) approval\n* Females only: Pregnant or breastfeeding\n* Any malabsorption condition\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Diagnosis of congenital long QT syndrome\n* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG)\n* Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug\n* Patients with active interstitial lung disease (ILD) \u002F pneumonitis or with a history of ILD\u002F pneumonitis requiring steroids\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":292,"type":21},32,[56],"This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving BgRT with SBRT and osimertinib may kill more tumor cells in patients with oligoprogressive EGFR positive non-small cell lung carcinoma.",[27,131],"2026-05-05",{"date":298,"type":37},"2026-05-07",{"date":300,"type":37},"2024-10-09",{"date":302,"type":21},"2026-07-11",{"name":304,"class":68},"City of Hope Medical Center",2,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":327},"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":314,"type":21},88,[56],"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.",[27],"2026-05-04",{"date":320,"type":37},"2026-05-06",{"date":322,"type":37},"2024-11-19",{"date":159,"type":21},{"name":325,"class":326},"SWOG Cancer Research Network","NETWORK",248,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":162},"100617824","phase-2-telisotuzumab-vedotin-and-osimertinib-for-the-treatment-of-progressive-incurable-non-small-cell-lung-cancer-100617824","NCT07323641","Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer","A Phase II Trial of Telisotuzumab Vedotin With Osimertinib for EGFR Mutated NSCLC With c-MET Overexpression That is Progressing on Osimertinib","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age and willing and able to provide informed consent\n* Cytologically or histologically confirmed non small cell lung cancer (NSCLC), which is incurable with an activating and sensitizing EGFR mutation (e.g., exon 20 insertion mutations are excluded). Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to osimertinib. T790M mutations and identified EGFR mutations that are known to confer resistance to osimertinib (for instance C797S) are allowed\n* Predominantly adenocarcinoma histology. (Small cell or predominantly squamous cell or sarcomatoid\u002Fpleiomorphic histologies are excluded.)\n* Progressed on osimertinib. Osimertinib must have been included in the last systemic therapy prior to trial enrollment and the patient must be considered appropriate for continuation of osimertinib at 80 mg daily per the treating investigator\n* From a tumor specimen obtained following progression on osimertinib or within 4 months of study entry (as long as the specimen was obtained after osimertinib was started), subjects must have c-MET overexpressing NSCLC as assessed by a Certified Laboratory Improvement Amendments (CLIA)-certified laboratory using the VENTANA MET (SP44) RxDx assay, with intermediate or high expression, defined as either ≥ 25% and \\\u003C 50% (intermediate) or ≥ 50% (high). If local results are unavailable, central testing may be performed\n* Measurable disease, as per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Able to swallow the oral study drug, has no known intolerance of study drugs or excipients, and able to comply with study requirements\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n* Platelets ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated\\* creatinine clearance ≥ 50 mL\u002Fmin (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n  * Creatinine clearance may be calculated using a 24 hour urine collection, by the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) per the Modification of Diet in Renal Disease (MDRD) GFR equation\n* Serum total bilirubin ≤ 1.5 X ULN OR direct bilirubin ≤ ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for participants with liver metastases\n* Albumin ≥ 3.0 g\u002FdL\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum test must be negative for pregnancy for the participant to be eligible. Female participants must agree to use a highly effective method of contraception from the beginning of screening until 7 months after the last dose of the telisotuzumab vedotin, or be of nonchildbearing potential.Nonchildbearing potential is defined as follows (by other than medical reasons):\n\n  * ≥ 45 years of age and has not had menses for \\> 2 years, in the absence of conditions that could lead to amenorrhea (i.e., post chemotherapy),\n  * Participants who have been amenorrhoeic for \\\u003C 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation, or\n  * Surgical sterilization (Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation)\n* Male patients having sex with a female partner of childbearing potential or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 4 months after the last dose of telisotuzumab vedotin\n* Male and female participants must agree not to donate sperm or eggs, respectively starting from the first study-drug treatment, Men must not donate sperm during trial therapy and for 4 months after receiving the last dose of study medication and women must not donate eggs during trial treatment and for 7 months after receiving the last dose of study medication\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study\n* Prior c-MET targeted antibody drug conjugate with a microtubule toxin (such as monomethylauristatin E \\[MMAE\\]). Prior MET antibody without a toxin, prior MET antibody drug conjugate (ADC) with a non-microtubule, and prior MET TKI therapy are acceptable\n* Any chemotherapy, immunotherapy, biologic, hormonal therapy, or investigational systemic therapy for cancer treatment in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable\n* Thoracic radiation of ≥ 30 grey (Gy) within 6 months. Other radiation within 2 weeks with the exception: Stereotactic, palliative radiation for bone metastases is acceptable without a washout as long as no lung parenchyma was included in the radiation field\n* Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded\n* Has not recovered (recovery is defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events \\[CTCAE v 5.0\\] grade ≤ 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion. Other grade 2 or less toxicities not constituting a safety risk based on the investigator's judgment are acceptable.\n\n  * Subjects with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for the study\n* Subject must not have a history of idiopathic lung disease, drug-induced idiopathic lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Major surgical procedures or serious trauma within 4 weeks prior to cycle (C) 1 day (D) 1, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) do not require a washout\n* The patient has any ongoing or active infection requiring the use of parenteral anti-microbial agents. Patient with a history of HIV with an undetectable viral load and a CD4 count over 200 are eligible. Patients with a history of hepatitis B or hepatitis C, an undetectable viral load, and liver function tests (LFT) testing which meets criteria for the study are eligible\n* History of another cancer within 2 years of study initiation, with the exception of fully treated cancers unlikely to affect the assessment of the study treatment safety or efficacy including early-stage breast, prostate, bladder, non-melanomatous skin, thyroid, cervical, or endometrial cancer. Additionally, subjects must not be receiving any ongoing anti-cancer therapy, including maintenance therapy, prior to randomization. Hormonal therapy is allowed provided that the participant otherwise meets trial criteria\n* Participants must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to uncontrolled ventricular arrhythmia, myocardial infarction within 6 months, stroke within 6 months, clinically significant electrocardiogram (ECG) abnormalities, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis, grade ≥ 2 edema or lymphedema, grade ≥ 2 ascites or pleural effusion, grade ≥ 2 neuropathy, grade ≥ 2 corneal disorder as assessed by a baseline ophthalmic exam, or any psychiatric disorder that prohibits obtaining informed consent\n* Patient unwilling or unable to comply with the protocol\n* Any condition that, in the opinion of the investigator or sponsor-investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results",{"count":336,"type":21},60,[56],"This phase II trial tests how well telisotuzumab vedotin and osimertinib works for the treatment of non small cell lung cancer that is growing, spreading, or getting worse (progressive) and for which no treatment is currently available (incurable). Telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin. Telisotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as c-Met receptors, and delivers vedotin to kill them. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving telisotuzumab vedotin and osimertinib may be effective for treating progressive, incurable non small cell lung cancer.",[27],"2026-04-15",{"date":342,"type":37},"2026-04-20",{"date":344,"type":37},"2026-02-19",{"date":346,"type":21},"2028-02-01",{"name":348,"class":68},"Jonsson Comprehensive Cancer Center",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},"100615086","phase-2-immunotherapy-biomarkers-to-predict-first-line-pdl1-based-immunotherapy-response-and-selection-of-second-line-treatment-in-stage-iiib-iv-non-small-cell-lung-cancer-immuno-biomap-trial-100615086","NCT07288034","Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial","Immunotherapy Biomarker Collection for Metastatic NSCLC to Inform Adaptive Personalized Models Targeting Resistance (IMMUNO-BIOMAP)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative. (Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure compliance.)\n* Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR B) archival or new biopsy tissue available (to be sent to Tempus). Acceptable sample types include: two formalin-fixed paraffin-embedded (FFPE) tissue core biopsies, or two 25um sections of 5-10mm\\^2 tissue, or 15-20 unstained slides at 10um thickness (a minimum of 10 unstained slides must be provided)\n* Agreement to blood collection for ctDNA research\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed stage IIIB or IV NSCLC\n* Absence of sensitizing EGFR mutation or ALK\u002FROS1 alteration\n* Scheduled to begin treatment with a Food and Drug Administration (FDA) approved PD1\u002FPDL1 antibody with or without chemotherapy. Participants who have already started treatment with anti-PD1\u002FPDL1 in this setting may enroll if they have only received up to 4 cycles of treatment so far. Patients who have received PD1\u002FPDL1 antibody for early-stage NSCLC are allowed to enroll if they completed the therapy at least 6 months before starting trial therapy\n* Measurable disease by RECIST version (v) 1.1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n* If seropositive for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* PART II: Documented informed consent (for Part II) of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PART II: ECOG ≤ 2\n* PART II: Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* PART II: ANC ≥ 1,500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* PART II: Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* PART II: Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment\n* PART II: Total bilirubin ≤ 1.5 x ULN\n* PART II: AST ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* PART II: ALT ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)\n* PART II: Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement\n* Patients with a condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Radiation therapy within 7 days prior to day 1 of protocol therapy\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association \\[NYHA class\\] ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs\n* Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable\n* Prior history of interstitial lung disease (ILD) or non-infectious pneumonitis requiring high-dose glucocorticoids\n* Active infection requiring antibiotics\n* Other active malignancy. Patients with concurrent malignancy other than non-melanoma skin cancer are not eligible for this trial due to potential confounding of the ctDNA results\n* Females only: Pregnant or breastfeeding\n* PART II: Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement\n* PART II: Radiation therapy within 7 days prior to day 1 of protocol therapy\n* PART II ARM A ONLY: Patients with a condition requiring systemic treatment with corticosteroids (\\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* PART II ARM A ONLY: Patients with prior history of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) treatment\n* PART II ARM B ONLY: Patients with prior history of KRAS G12C inhibitors\n* PART II: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication\n* PART II ARM A ONLY: Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs\n* PART II ARM B ONLY: Grade ≥ 2 proteinuria as demonstrated by ≥ 2+ protein and ≥ 1.0 g of protein with 24-hour urine collection (patients found to have ≥ 2+ protein on dipstick urinalysis must have 24-hour urine collection and demonstrate \\\u003C 1g of protein in 24 hours in order to be eligible for treatment)\n* PART II: Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable\n* PART II: Clinically significant uncontrolled illness\n* PART II: Active infection requiring antibiotics\n* PART II: Other active malignancy\n* PART II FEMALES ONLY: Pregnant or breastfeeding\n* PART II: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures",{"count":357,"type":21},535,[56],"This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD\\[L\\]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab 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). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and\u002For effective in treating patients with stage IIIB\u002FIV NSCLC with specific genetic mutations.",[27,32,131],"2026-04-13",{"date":340,"type":37},{"date":364,"type":37},"2026-04-08",{"date":366,"type":21},"2028-10-08",{"name":304,"class":68},13,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":376,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":162},"100358517","dyadic-yoga-intervention-in-improving-physical-performance-and-quality-of-life-in-patients-with-stage-i-iv-non-small-cell-lung-or-esophageal-cancer-undergoing-radiotherapy-and-their-caregivers-100358517","NCT03948100","Dyadic Yoga Intervention in Improving Physical Performance and Quality of Life in Patients With Stage I-IV Non-small Cell Lung or Esophageal Cancer Undergoing Radiotherapy and Their Caregivers","Dyadic Behavioral Interventions to Manage Physical Performance, Symptoms and Quality of Life for Patient Undergoing Radiotherapy and Their Family Caregivers","Inclusion Criteria:\n\n* PATIENT ONLY: Diagnosed with stage I-IV non-small cell lung cancer (NSCLC) or esophageal cancer and going to receive at least 3 weeks of thoracic radiotherapy (RT)\n* PATIENT ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* PATIENT ONLY: Able to read, write and speak English\n* PATIENT ONLY: Able to provide informed consent\n* PATIENT ONLY: Having a family caregiver (e.g., spouse, sibling, adult child) who assists the patient during the cancer treatment (e.g., emotional support, transportation, meal preparation, care coordination, etc) per patient self-report. Note, patients must identify a family caregiver; however, the participation of the family caregiver is optional. For caregivers to be eligible, they must be at least 18 years old; able to read, write and speak English; and able to provide informed consent. Family caregivers may consent to participate in the intervention and caregiver assessments or only the assessments based on their preference.\n\nExclusion Criteria:\n\n* PATIENT ONLY: Who have regularly (self-defined) participated in a mind-body practice in the year prior to diagnosis\n* PATIENT ONLY: Patients who metastatic disease involving the central nervous system",true,{"count":378,"type":21},400,[151],"This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy and their caregivers. Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with non-small cell lung cancer and\u002For their caregivers.",[208,27,252,382,383,384,385,30,386,387,388,31,32,177,131,389,390],"Stage IA1 Lung Cancer AJCC v8","Stage IA2 Lung Cancer AJCC v8","Stage IA3 Lung Cancer AJCC v8","Stage IB Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-04-10",{"date":340,"type":37},{"date":394,"type":37},"2018-12-20",{"date":396,"type":21},"2027-04-30",{"name":398,"class":68},"M.D. Anderson Cancer Center",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":162},"100566840","phase-2-grid-radiation-therapy-for-the-treatment-of-stage-iv-non-small-cell-lung-cancer-100566840","NCT06660407","Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer","Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2\n* Stage IV non-small cell lung cancer progressing after immunotherapy or chemoimmunotherapy\n* Extracranial lesion ≥ 3 cm amenable to grid therapy\n\n  * Patients with brain metastases are permitted to enroll if all of the following are true:\n\n    * They are stable (without evidence of progression by imaging ≤ 30 days prior to enrollment and any neurologic symptoms have returned to baseline)\n    * Have no evidence of new or enlarging brain metastases, and\n    * Are not using steroids ≤ 14 days prior to enrollment\n* Patients may receive conventional palliative radiation or stereotactic body radiotherapy (SBRT) to other metastatic sites (provided there is at least one non-irradiated lesion evaluable for response)\n* Negative pregnancy test done ≤ 7 days prior to radiation therapy for females of childbearing potential only\n* Provide written informed consent\n* Willing to provide mandatory blood specimens for correlative research\n* Willing to either return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study) or willing to have virtual visits and blood draws done locally\n* Estimated by investigator to have a life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Active autoimmune disease requiring systemic treatment, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents\n\n  * NOTE: Exceptions are allowed for:\n\n    * Vitiligo\n    * Resolved childhood asthma\u002Fatopy\n    * Intermittent use of bronchodilators or inhaled steroids\n    * Daily steroids at dose of ≤ 10mg of prednisone (or equivalent)\n    * Local steroid injections\n    * Stable hypothyroidism on replacement therapy\n    * Stable diabetes mellitus on non-insulin therapy\n    * Sjogren's syndrome\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring systemic therapy\n  * Interstitial lung disease\n  * Serious, chronic gastrointestinal conditions associated with diarrhea (e.g., Crohn's disease or others)\n  * Known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive)\n\n    • Known active hepatitis C (i.e., positive for hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] detected by polymerase chain reaction \\[PCR\\])\n  * Known active tuberculosis (TB)\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Unstable cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements (e.g., substance abuse)\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Hypersensitivity to immunotherapy\n* Previous adverse event attributed to immunotherapy that led to drug discontinuation\n* History of grade 3+ immune-related adverse event or any grade of immune-related neurologic or ocular adverse event while receiving immunotherapy\n\n  * Note: Patients who had endocrine adverse events ≤ grade 2 are allowed to enroll if they are stable on appropriate replacement therapy and asymptomatic\n* Other active malignancy \\\u003C 6 months prior to registration\n\n  * EXCEPTIONS: Non-melanotic skin cancer, papillary thyroid cancer, prostate cancer, or carcinoma-in-situ of the cervix, or others curatively treated and now considered to be at less than 30% risk of relapse\n* History of allogenic organ transplantation\n* History of active primary immunodeficiency\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice)\n* Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA",{"count":407,"type":21},20,[56],"This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size of a tumor), and above average local control rates often exceeding those expected with conventionally delivered radiation treatments, all with minimal associated toxicity. Immunotherapy has become combined into treating patients, which has led improvements in survival and quality of life. Immunotherapy is now the cornerstone of SOC therapy for stage IV NSCLC. Grid radiation therapy combined with immunotherapy may be safe and effective in treating patients with stage IV NSCLC.",[27,131],"2026-04-09",{"date":361,"type":37},{"date":414,"type":37},"2024-11-14",{"date":416,"type":21},"2027-01-10",{"name":237,"class":68},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":162},"100578875","lumbar-punctures-for-the-detection-of-ctdna-in-the-cerebrospinal-fluid-of-patients-with-stage-iii-and-iv-non-small-cell-lung-cancer-100578875","NCT06816979","Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer","Assessing the CSF-ctDNA of Patients With Stage III and IV Non-Small Cell Lung Cancer: A Pilot Study","Inclusion Criteria:\n\n* New histological diagnosis of stage III or IV NSCLC\n* For stage III\u002FIV NSCLC patients without brain metastases, a documented mutation on lung cancer mutation panel (PULMOL) is required\n* Patient treated with radiation therapy and\u002For systemic therapy at Ohio State University\n* Estimated survival \\>= 1 year\n* No medical contraindication to lumbar puncture\n\nExclusion Criteria:\n\n* Patient has Alzheimer's, dementia, or mental disability\n* Patient is not able to receive MRI\n* Patient has allergy to xylocaine or any numbing medication for lumbar puncture\n* Previous cancer history prior to diagnosis of NSCLC\n* Pregnant or lactating women, or women of childbearing potential and men who are sexually active and not willing\u002Fable to use medically acceptable forms of contraception; this exclusion is necessary because the medication and radiation required for standard of care treatment has unknown effects on the unborn fetus",{"count":426,"type":21},40,[151],"This phase I trial assesses the use of lumbar punctures to detect whether there is circulating tumor deoxyribonucleic acid (ctDNA) in the fluid that surrounds the brain and spinal cord (cerebrospinal fluid) in patients with stage III and IV non-small cell lung cancer (NSCLC). Patients with stage III and IV NSCLC are at risk of having their cancer spread from where it first started to the brain (metastatic). Because of this, more effective prognostic tools are necessary to determine which stage III and IV NSCLC patients are more likely to develop brain metastases. Cerebrospinal fluid (CSF) could be a reliable source of ctDNA to confirm and predict the presence of brain metastases in these patients. Assessing cell free DNA shed from tumor cells could be a sensitive and minimally invasive way to detect or characterize metastatic tumors in the central nervous system (CNS). Lumbar puncture is procedure in which a thin needle called a spinal needle is put into the lower part of the spinal column to collect CSF. Lumbar punctures for the collection of CSF may help doctors detect or measure changes in cell types, genes, and proteins of circulating tumor cells related to lung cancer that will help determine the presence of brain metastases which could become a standard of care screening tool utilized in the follow-up of patients diagnosed with stage II or IV NSCLC.",[27,388,131],"2026-04-02",{"date":364,"type":37},{"date":433,"type":21},"2026-09-15",{"date":435,"type":21},"2028-01-31",{"name":437,"class":68},"Ohio State University Comprehensive Cancer Center",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":447,"phases":4,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":305},"100607295","qualitative-study-on-detection--tx-of-nsclc-in-pts-w-a-history-of-alcohol-or-sud-100607295","NCT07186699","Qualitative Study on Detection & Tx of NSCLC in Pts w\u002F a History of Alcohol or SUD","Qualitative Study on Detection and Treatment of Non-Small Cell Lung Cancer in Patients With a History of Alcohol or Substance Use Disorder","Inclusion Criteria:\n\n* \\* Adults ≥ 18 years of age\n\n  * Histopathologic or cytologic diagnosis of NSCLC\n  * Received or receiving curative intent treatment (e.g. surgery, radiation therapy, systemic therapy)\n  * History of alcohol use or substance use disorder (other than tobacco use disorder) within the past 10 years, predating the cancer diagnosis\n  * Ability to understand and the willingness to sign a written informed consent\n  * English or Spanish speaking. Due to need to conduct semi-structured interviews which can develop into free-flowing conversations we need both participant and interviewer to be fluent\n\nExclusion Criteria:\n\n* Patients with cognitive disability unable to maintain 30-60 minute conversation",{"count":446,"type":21},45,"OBSERVATIONAL","This study will attempt to identify social facilitators and barriers to detection and treatment of non-small cell lung cancer in order to learn how a history of substance abuse or alcohol use impacts care for non-small cell lung cancer.",[27],"2026-03-27",{"date":430,"type":37},{"date":453,"type":37},"2025-09-29",{"date":455,"type":21},"2028-09-12",{"name":457,"class":68},"University of Southern California",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":447,"phases":4,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":483},"100548223","assessing-benefits-and-harms-of-cannabiscannabinoid-use-among-cancer-patients-treated-in-community-oncology-clinics-100548223","NCT06418204","Assessing Benefits and Harms of Cannabis\u002FCannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics","Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics","COSMIC","Inclusion Criteria:\n\n* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).\n* Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and\u002For immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.\n* Participants must be able to comprehend English or Spanish (for survey completion).\n* Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.\n* Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.\n* Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey\n* In the treating provider's opinion, the participant should have a life expectancy of \\>=6 months. Participants in hospice are not eligible.\n\nOptional Sub-study (available at select sites only):\n\n* Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).\n* Must be receiving treatment at the WF CCC and VCU.\n* Must be diagnosed with non-small cell lung cancer.\n* Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.\n\nExclusion Criteria:\n\n* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.\n* Participants with known pregnancy.\n* Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.\n* Participants enrolled in hospice.\n\nOptional Substudy (available at select sites only):\n\n* Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.\n* Participants with a history of HIV, hepatitis B or hepatitis C.",{"count":467,"type":21},2000,"This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and\u002For (immune checkpoint inhibitors) ICIs.",[470,471,27,472,473],"Breast Carcinoma","Colorectal Carcinoma","Melanoma","Non-Hodgkin Lymphoma","2026-03-16",{"date":476,"type":37},"2026-03-17",{"date":478,"type":37},"2025-01-30",{"date":480,"type":21},"2028-08-01",{"name":482,"class":68},"Wake Forest University Health Sciences",467,{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":447,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":305},"100619025","experiences-w--attitudes-towards-immune-chckpt-inhibitors-in-nsclc-patients-single-center-survey-based-study-100619025","NCT07339254","Experiences w\u002F & Attitudes Towards Immune Chckpt Inhibitors in NSCLC Patients Single Center Survey Based Study","Experiences With and Attitudes Towards Immune Checkpoint Inhibitors in Patients With Non-Small Cell Lung Cancer (NSCLC) - A Single Center, Survey-Based Study","Inclusion Criteria:\n\n* \\* Age ≥ 18 years.\n* \\* Patients must have histopathologically\u002Fcytologically confirmed non-small cell lung cancer, currently receiving Atezolizumab, Cemiplimab, Durvalumab, Nivolumab, Pembrolizumab (i.e. the patient has already received at least one cycle of therapy)\n* \\* Previous chemotherapy\u002Fradiotherapy\u002Ftargeted\u002Fimmunotherapy is allowed at any prior timepoint.\n* \\* Ability to understand and the willingness to sign a written informed consent or presence of a surrogate decision maker who can give consent.\n\nExclusion Criteria:\n\n* \\* Patients is unable to consent for themselves\n* \\* Patient has not yet completed the 1st cycle of ICI-based therapy",{"count":426,"type":21},"This study evaluates patient satisfaction with receiving intravenous (IV) and\u002For subcutaneous (SC) immunotherapy and to assess patient preference for IV immunotherapy administration versus SC immunotherapy administration either at the hospital or at home.",[27],"2026-03-13",{"date":474,"type":37},{"date":497,"type":37},"2026-03-12",{"date":499,"type":21},"2028-03-12",{"name":457,"class":68},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":162},"100348630","phase-1-role-of-gut-microbiome-and-fecal-transplant-on-medication-induced-gi-complications-in-patients-with-cancer-100348630","NCT03819296","Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer","Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population","Inclusion Criteria:\n\n1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).\n2. Diagnosis of any cancer type (Projects 2 and 3)\n3. Treatment with any ICPI agent\n4. Ability to understand and willingness to sign an informed consent form and rate surveys\n5. Life expectancy \\> 4 months (Project 3)\n6. ICPI-related diarrhea and\u002For colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)\n7. Patients with no organ toxicity as the control group (project 1)\n8. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)\n9. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)\n10. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):\n\n    (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,\n\n    (ii) contraindication for immunosuppressive treatment,\n\n    (iii) recurrence after successful initial treatment,\n\n    (iv) recurrent symptoms once steroid is tapered down\u002Foff or diarrhea\u002Fcolitis symptoms are steroid dependent, or\n\n    (v) patients with a history of refractory ICPI-related colitis and\u002For diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT\n11. No concern for active concomitant GI infection for the ICPI diarrhea\u002Fcolitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)\n12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea\u002Fcolitis treatment (project 3)\n\nExclusion Criteria:\n\n1. Age younger than 18 years\n2. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n3. Pregnant and breastfeeding women\n4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)\n6. Patients with active bacterial or fungal infection (Project 3)\n7. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire (Project 3)\n\nWithdrawal Criteria\n\n1. Patients may withdraw from the trial at any time\n2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis\n3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated",{"count":509,"type":21},800,[128],"This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.",[513,514,515,516,517,518,202,203,204,206,519,27,520,212,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,252,382,383,384,385,30,386,387,388,31,32,177,131,389,390],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Colitis","Malignant Genitourinary System Neoplasm","Pathologic Stage 0 Cutaneous Melanoma AJCC v8","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Stage 0 Lung Cancer AJCC v8","2026-03-10",{"date":538,"type":37},"2026-03-11",{"date":540,"type":37},"2021-02-21",{"date":542,"type":21},"2026-10-31",{"name":398,"class":68},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":376,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":559,"locationsCount":162},"100525463","a-tool-for-improving-the-shared-decision-making-process-in-patients-with-non-small-cell-lung-cancer-100525463","NCT06122064","A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer","Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial","Inclusion Criteria:\n\n* CLINICIANS:\n* All clinicians within identified departments participating are eligible (doctor of medicine \\[MD\\]\u002Fdoctor of osteopathy \\[DO\\], fellows\u002Fresidents, physician assistant \\[PA\\]\u002Fnurse practitioner \\[NP\\])\n* PATIENTS:\n* Adult patients (\\>= 18 years of age)\n* Appointments at Mayo Clinic in Rochester\n* Non-small cell lung cancer (NSCLC) stage \\> 1B\n* Eligible by their oncologist for adjuvant treatment\n\nExclusion Criteria:\n\n* Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)",{"count":149,"type":21},[151],"This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.",[27,30,388,131],"2026-03-06",{"date":536,"type":37},{"date":257,"type":37},{"date":542,"type":21},{"name":237,"class":68},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":305},"100490898","phase-2-phase-ii-trial-of-lung-chemoemobolization-100490898","NCT05672108","Phase II Trial of Lung Chemoemobolization","Inclusion Criteria:\n\n* Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to resection, thermal ablation, or ablative radiation therapy\n* Lung-dominant disease (majority of active tumor volume is in the chest)\n* At least 18 years old\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Oxygen saturation \\< 92% on room air\n* Forced expiratory volume in 1 second (FEV1) \\< 60%\n* No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all \\< 1 cm)\n* Life expectancy \\< 6 months\n* Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging \\[MRI\\], or direct pressure measurement)\n* Recent pulmonary embolism (within 3 months)\n* Pulmonary arteriovenous malformation\n* Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)\n* Symptomatic heart failure (American College of Cardiology \\[ACC\\]\u002FAmerican Heart Association \\[AHA\\] stage C or D)\n* Left bundle branch block (contraindication to pulmonary angiography)\n* Renal failure (estimated glomerular filtration rate \\[eGFR\\] \\< 30 mL\u002Fmin\u002F1.73 m\\^2)\n* Pregnancy or intent to become pregnant\n* Breast feeding\n* Altered mental status that would interfere with consent or follow-up\n* Platelets \\< 50,000 (after transfusion, if needed)\n* International normalized ratio (INR) \\> 2 (after transfusion, if needed)\n* Hemoglobin \\< 7 (after transfusion, if needed)\n* Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)\n* Planned radioactive iodine imaging or therapy (contraindication to lipiodol)\n* Allergy to lipiodol or mitomycin\n* Allergy to iodinated contrast that cannot be treated with steroid \u002F diphenhydramine premedication\n* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety",{"count":126,"type":21},[56],"This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor\\'s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.",[27,570,571,572,573,574,575],"Mediastinal Neoplasm","Pleural Neoplasm","Lung Metastases From Any Primary","Endobronchial Metastases","Colon Cancer","Sarcoma","2026-03-03",{"date":578,"type":37},"2026-03-05",{"date":580,"type":37},"2023-05-12",{"date":582,"type":21},"2027-10-28",{"name":304,"class":68},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":162},"100586650","phase-2-cemiplimab-and-fianlimab-before-surgery-for-the-treatment-of-stage-ib-iiib-non-small-cell-lung-cancer-100586650","NCT06918132","Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer","Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)","N-PLANC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics:\n\n  * Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition\n  * T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm). All other T4 tumors will be ineligible.\n  * Pathologic status of lymph nodes must be known for suspicious or enlarged lymph nodes. Note: suspicious or enlarged lymph nodes must be discussed with sponsor\u002Fprincipal investigator.\n  * PD-L1 expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC)\n\n    * Group A: PD-L1 expression ≥ 1% \\\u003C 50%\n    * Group B: PD-L1 expression ≥ 50%\n  * Complete surgical resection of the primary NSCLC must be deemed achievable by thoracic surgeon at screening\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Adequate pulmonary function ascertained by treating surgeon obtained ≤ 30 days prior to registration. A pre- or post-bronchodilator forced expiratory volume in 1 second (FEV1) of 1.0 L or \\> 40% postoperative predicted value or diffusing capacity of the lungs for carbon monoxide (DLCO) \\> 40% predicted value are required prior to enrollment\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ highly effective contraception during the study and up to 6 months after the last dose\n* Presence of targetable alterations \\[Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)\\] in tumor\n* Unresectable or metastatic disease\n* Active or history of the following:\n\n  * Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol\n  * Interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or pneumonitis within the last 5 years\n  * Autoimmune disease (including any history of inflammatory bowel disease)\n  * Any syndrome that required systemic steroids or immunosuppressive medications EXCEPTIONS: patients with vitiligo; resolved childhood asthma\u002Fatopy; residual hypothyroidism that requires only hormone replacement; or psoriasis not requiring systemic treatment, type-1 diabetes mellitus, or rheumatoid arthritis managed without disease modifying anti-rheumatic drugs or \\>10 mg prednisone equivalent\n* Patients requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days prior to registration.\n\nNOTE: Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n\n* Patients with organ transplantation\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; or prior immune-related myocarditis\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Uncontrolled infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\nNote: No testing is required for this study unless mandated by local health authority.\n\nEXCEPTIONS:\n\n* Patients with known HIV who have controlled infection \\[undetectable viral load and cluster of differentiation 4 (CD4) count above 350 either spontaneously or on a stable antiviral regimen\\] are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n* Patients with known hepatitis B (hepatitis B surface antigen positive \\[HBsAg+\\]) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV ribonucleic acid (RNA) by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n\n  * Receiving any other investigational agent which would be considered as a treatment for the primary malignancy\n  * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n  * Known hypersensitivity to the active substances or to any of the excipients\n  * Receipt of live vaccine ≤ 30 days prior to registration",{"count":336,"type":21},[56],"This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.",[27,385,30,31,32],"2026-02-20",{"date":598,"type":37},"2026-02-24",{"date":600,"type":37},"2025-04-29",{"date":602,"type":21},"2027-04-29",{"name":237,"class":68}]