[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-non-small-cell-lung-cancer":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,115,145,179,211,241,263,290],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100301098","beating-lung-cancer-in-ohio-protocol-in-improving-survival-in-patients-with-stage-iv-non-small-cell-lung-cancer-100301098",false,"NCT03199651","Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer","Beating Lung Cancer in Ohio (BLCIO) Protocol","BLCIO","Inclusion Criteria:\n\n* AIM 1-3\n* Pathologically confirmed stage IV NSCLC (with any Eastern Cooperative Oncology Group \\[ECOG\\] performance status, and any NSCLC - adenocarcinoma, squamous cell, etc.) with available imaging OR patients who do not yet have their staging completed, but in the judgment of the physician are likely to be stage IV;\n\n  * Patients may be enrolled if the recruiter cannot reach the patient by the first office visit, preferably prior to starting therapy and no later than one month after starting therapy; (NCCN guidelines allow for a switch to targeted therapy from chemotherapy if testing comes back positive after starting chemotherapy)\n* English speaking; and\n* Willing to provide access to medical records, insurance and billing data, biospecimens and respond to questionnaires, typically by phone, but possibly to include online or in-person surveys\n* AIM 3 ONLY\n* Patients must be current smokers who smoke at least one cigarette most days per week, or recent quitters who smoked at least one cigarette most days per week (\\\u003C 3 months); and\n* Household members must be current smokers, defined as smoking at least one cigarette most days per week\n* Hearing and vision impairments that would prevent ability to complete consent, interviews, or sample collection\n\nExclusion Criteria:\n\n* Being treated with definitive chemoradiotherapy or surgery\n* Receiving treatment for advanced lung cancer for over one month before enrollment; OR","ALL","18 Years",{"count":20,"type":21},3584,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong survival, have more favorable toxicity profiles than conventional chemotherapy and impact quality of life.",[27,28,29,30,31],"Cigarette Smoker","Current Smoker","Lung Adenocarcinoma","Squamous Cell Lung Carcinoma","Stage IV Non-Small Cell Lung Cancer","RECRUITING","2026-06-15",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":36},"2017-07-17",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100467009","phase-1-a-study-to-investigate-the-efficacy-and-safety-of-an-infusion-of-iov-4001-in-adult-participants-with-unresectable-or-metastatic-melanoma-or-stage-iii-or-iv-non-small-cell-lung-cancer-100467009","NCT05361174","A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","A Phase 1\u002F2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.\n2. Participants who have received the following previous therapy:\n\n   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1\u002FPD-L1 blocking antibody and received BRAF\u002FMEK inhibitor in those with BRAF mutations.\n   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:\n\n      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n      * those with oncogene-driven tumors: Have progressed during\u002Fafter ≥1 targeted therapy AND either:\n\n        * platinum doublet chemotherapy\n        * Or within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Participants who is assessed as having at least one resectable lesion.\n5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.\n6. Participants who have adequate organ function.\n7. Cardiac function test required.\n8. Pulmonary function test may be required.\n9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.\n10. Participants who are \\>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participants who have melanoma of uveal\u002Focular origin.\n2. Participants who have symptomatic untreated brain metastases.\n3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n4. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n5. Participants who have any form of primary immunodeficiency.\n6. Participants who have another primary malignancy within the previous 3 years.\n7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.","70 Years",{"count":54,"type":21},53,[56,57],"PHASE1","PHASE2","This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).",[60,61,62,63],"Unresectable Melanoma","Metastatic Melanoma","Stage III Non-small Cell Lung Cancer","Stage IV Non-small Cell Lung Cancer",[65,66,60,61,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Tumor Infiltrating Lymphocytes","TIL","Stage III Non-small-cell lung cancer","Stage IV Non-small-cell lung cancer","PD-1 Knockout","Cell Therapy","Autologous Adoptive Cell Therapy","Cellular Immuno-therapy","IL-2","Non Small Cell Lung Cancer","NSCLC","Second line Lung Cancer","Bronchial Neoplasms","Carcinoma","Lung Disease","Metastatic Lung Cancer","Metastatic Non Small Cell Lung Cancer","Lung Carcinoma","PD-L1","Stage IV Cancer","Stage IV Lung Cancer","Stage IV NSCLC","Systemic Therapy","2nd line therapy","Second line therapy","CPI","Check point inhibitor","Metastatic NSCLC","NSCLC Recurrent","Recurrent Lung Cancer","Recurrent Lung Carcinoma","Autologous Adoptive Cell Transfer","Melanoma","Lifileucel","Stage III Melanoma","Stage IV Melanoma","Skin cancer","Skin cancer types","Malignant melanoma","2026-06-10",{"date":106,"type":36},"2026-06-11",{"date":108,"type":36},"2022-07-20",{"date":110,"type":21},"2029-09",{"name":112,"class":113},"Iovance Biotherapeutics, Inc.","INDUSTRY",11,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":44},"100491642","phase-1-clinical-trial-of-cd40l-augmented-til-for-patients-with-egfr-alk-ros1-or-her2-driven-nsclc-100491642","NCT05681780","Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC","Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with an activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains\n* ECOG performance status of 0 or 1\n* Expected survival ≥ 4 months\n* Participants must have had disease progression after at least one prior line of systemic therapy for NSCLC, including appropriate prior targeted therapy for cases in which a targeted therapy is conventionally used for this genomic alteration, prior to initiating nivolumab trial therapy\n* Measurable disease, not including any lesion that is used for TIL harvest, prior to initiation of nivolumab trial therapy\n* In accordance with the criteria above, safely accessible tumor for TIL harvest by excisional biopsy expected to yield 1.5 cm3 of tissue, in aggregate\n* Participants with known brain metastases are eligible for study enrollment if the brain metastases have received appropriate central nervous system-directed therapy or are found to be clinically stable ≤ 10 mm when comparing scans obtained during the screening period with a scan obtained ≥28 days prior, or if the treating physician determines that immediate CNS-specific treatment is not required prior to the first cycle of therapy. Please also refer to eligibility section on corticosteroids below.\n* Adequate normal organ and marrow function as defined below:\n* a. Hemoglobin ≥ 9.0 g\u002FdL, with transfusions permissible;\n* b. Absolute neutrophil count (ANC) ≥ 1000 per mm3);\n* c. Platelet count ≥ 75,000 per mm3, without platelet transfusions for 7 days;\n* d. Prothrombin Time ≤ 1.7x the institutional upper limit of normal (ULN), unless participant is receiving intended anticoagulant therapy.\n* e. Serum bilirubin ≤ 2.0x the institutional ULN, or ≤ 4.0x ULN if confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology) with PI approval.\n* f. AST\u002FALT ≤ 2.5x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN\n* g. Serum creatinine of ≤ 1.5x institutional ULN, or ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n* h. Albumin ≥ 2.0 g\u002Fdl\n* Pulmonary function tests within past 4 months showing DLCO ≥45% of predicted. Adjusted DLCO based on hemoglobin concentration should be used, if available.\n* Human immunodeficiency virus (HIV)-infected participants must be receiving on effective antiretroviral therapy for past 6 months with undetectable viral load and normal CD4 count\n* Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy, if indicated, and no overt cirrhosis\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they must have an undetectable HCV viral load and no overt cirrhosis\n* Participants with a prior or concurrent malignancy must have a natural history which does not have the potential to interfere with safety or efficacy assessment of the investigational regimen\n\nExclusion Criteria:\n\n* No more than six prior lines of systemic therapy for NSCLC\n* No prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC. Examples of inhibitors include: nivolumab, atezolizumab, pembrolizumab, avelumab, cemplimumab, spartalizumab, or durvalumab.\n* Participants with rapidly progressing tumors, as judged by the investigator\n* Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, limited site eczema, or limited site plaque psoriasis not requiring systemic treatment (within the past 2 years), or other autoimmune conditions which are not expected to recur, are allowed after approval from the medical monitor or PI\n* Active leptomeningeal or pachymeningeal metastases, or carcinomatous meningitis. This is due to prognostic implications and timeline for cell therapy\n* Has a diagnosis of primary immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* a. Oral hydrocortisone, only for the purposes of a documented adrenal insufficiency diagnosis, is permitted if ≤ 25 mg daily total dose\n* b. Inhaled, intranasal, or topical corticosteroids are permitted\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation or supraventricular tachycardia), and significant ≥85% carotid artery stenosis\n* Unresolved toxicity (grade 2) from previous anti-cancer therapy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)\n* Mean QT interval corrected for heart rate (QTc) ≥480 ms calculated from electrocardiograms (EKGs) using Bazett's Correction\n* Participants with active systemic infections requiring intravenous antibiotics within 1 week prior to nivolumab. Prophylactic, empiric, or suppressive antibiotics are permitted with sponsor approval\n* History of allogeneic organ transplant\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants with a history of anaphylaxis to beta-lactam antibiotics. Patients may be evaluated for reported history by conducting a history and physical, and a skin test\u002Fchallenge where appropriate under medical guidance",{"count":123,"type":21},20,[56],"To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.",[74,63,127],"Recurrent Non Small Cell Lung Cancer",[129,130,131,132,133,134,135],"Lung Cancer","Tumor-Infiltrating Lymphocytes","EGFR Mutation","ALK Rearrangement","ROS1 Rearrangement","ERBB2 Mutation","HER2 Exon 20 Mutation","2026-03-26",{"date":138,"type":36},"2026-03-31",{"date":140,"type":36},"2023-03-10",{"date":142,"type":21},"2027-12",{"name":144,"class":43},"H. Lee Moffitt Cancer Center and Research Institute",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":155,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100623087","peripheral-blood-etasts-for-predicting-efficacy-of-chemoimmunotherapy-in-nsclc-100623087","NCT07392073","Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC","Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)\n* Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed\u002Fcarboplatin)\n* Age 18-80 years\n* ECOG performance status 0-1\n* Expected survival ≥12 weeks\n* Adequate bone marrow function: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL\n* Adequate hepatorenal function: Cr ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN\n* At least one measurable lesion per RECIST 1.1 criteria\n* Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up\n\nExclusion Criteria:\n\n* No measurable disease per RECIST 1.1 criteria\n* Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome)\n* Active untreated central nervous system metastases or leptomeningeal disease\n* Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment\n* Chronic use of immunosuppressive agents (e.g., corticosteroids \\>10 mg\u002Fday prednisone equivalent)\n* Coagulation disorders (INR \\>1.5 or APTT \\>1.5×ULN) or ongoing anticoagulation therapy\n* Poor vascular access precluding serial venipuncture (\\>5 mL per draw)\n* Active hepatitis B (HBV DNA \\>2000 IU\u002FmL), hepatitis C, or HIV infection\n* Uncontrolled bacterial or fungal infection requiring systemic treatment\n* Pregnancy or lactation\n* Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance\n\nWithdrawal Criteria:\n\n* Participant voluntary withdrawal with signed withdrawal statement\n* Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)\n* Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor\n\nStudy Termination Criteria:\n\n* Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy\n* Death or loss to follow-up \\>6 months\n* Unacceptable grade 4 treatment-related toxicity\n* Investigator determination that continued participation poses health risk to patient\n* Study terminated by ethics committee for scientific or administrative reasons","80 Years",{"count":154,"type":21},80,"24 Months","OBSERVATIONAL","The goal of this observational study is to explore whether changes in peripheral blood effector tumor antigen-specific T cells (ETASTs) can predict treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) receiving chemoimmunotherapy. The study aims to:\n\n* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival\n* Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB)\n* Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy\n\nParticipants will:\n\n* Provide peripheral blood samples at baseline and after cycle 2 of treatment\n* Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles\n* Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria\n* Be followed for progression-free survival and overall survival up to 24 months",[159,29,160,161,31,162],"Non-Small Cell Lung Cancer","Lung Squamous Cell Carcinoma","Stage IIIB Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer",[164,165,166,167,168],"Tumor Antigen-Specific T Cells","Effector T Cells","Circulating T Cells","Biomarkers","PD-1 Inhibitor","NOT_YET_RECRUITING","2026-02-02",{"date":172,"type":36},"2026-02-06",{"date":174,"type":21},"2026-04",{"date":176,"type":21},"2029-06",{"name":178,"class":43},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":197,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":44},"100431655","patient-centered-optimal-integration-of-survivorship-and-palliative-care-100431655","NCT04900935","Patient-centered, Optimal Integration of Survivorship and Palliative Care","Inclusion Criteria:\n\n* Age 18 or older\n* MGH Cancer Center patient\n* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)\n* Receiving targeted therapy\n* Ability to respond in English or Spanish\n\nExclusion Criteria:\n\n* Cognitive impairment or serious mental illness that limits ability to provide informed consent\n* Need for urgent palliative care or hospice referral\n* Pregnant women\n* Prisoners",{"count":186,"type":21},70,[24],"The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are\n\n* is POISE feasible to deliver and acceptable to patients\n* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.",[63,190,191,192,193,194,195,196],"Targeted Therapy","Nonsmall Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","ALK-positive Non-small Cell Lung Cancer","EGFR Positive Non-small Cell Lung Cancer","Palliative Care","Survivorship",[63,190,191,192,193,194,198,199,200,201],"ROS1 Positive Non-Small Cell Lung Cancer","Palliative care","survivorship","RET Fusion positive Non-Small Cell Lung Cancer","2025-11-19",{"date":204,"type":36},"2025-11-24",{"date":206,"type":36},"2023-09-29",{"date":208,"type":21},"2027-09-01",{"name":210,"class":43},"Massachusetts General Hospital",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":228,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":123},"100586607","phase-2-palace-cemiplimab-trial-according-to-ctdna-levels-100586607","NCT06917573","PALACE: Cemiplimab Trial According to ctDNA Levels","Phase II Clinical Trial With an Adaptive Design According to Response to Cemiplimab Monotherapy Using ctDNA and Subsequent Treatment With Chemotherapy (CT) and Cemiplimab or Cemiplimab Monotherapy in First Line Advanced NSCLC Patients","PALACE","Inclusion Criteria:\n\n* Histologically confirmed stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy\n* PDL1 ≥50%\n* ECOG performance status 0-1\n* Patients aged ≥ 18 years\n* Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment\n* Presence of at least one measurable lesion by CT-scan per RECIST version 1.1\n* Anticipated life expectancy \\>12 weeks\n* Correct hematological, hepatic and renal function\n* Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements\n* Patients must be accessible for treatment and follow-up\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.\n* All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs\n\nExclusion Criteria:\n\n* Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy\n* Patients with grade ≥2 neuropathy\n* Pregnant or breastfeeding women\n* Patients with a weight loss \\>10% within the previous 3 months\n* Patients with carcinomatous meningitis\n* Patients with a history of other malignant diseases within the past 3 years\n* Patients must have recovered from a major surgery at least 14 days prior to enrolment\n* Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol\n* Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria\n* Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy\n* Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n* Has known allergy or hypersensitivity to components of study drug\n* Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments\n* Untreated brain metastasis(es) that may be considered active\n* Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab\n* Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency\n* History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n* History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments\n* Patients with a history of solid organ transplant\n* Receipt of live vaccines within 30 days of first study treatment\n* Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.",{"count":220,"type":21},63,[57],"This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.",[224,225,63,62,226,227],"Non Small Cell Lung Cancer Metastatic","Lung Diseases","Respiratory Tract Neoplasms","Thoracic Neoplasms",[229,230,231,232],"Cemiplimab","ctDNA levels","Chemotherapy","Non-resectable non-small cell lung cancer","2025-11-17",{"date":202,"type":36},{"date":236,"type":36},"2025-07-29",{"date":238,"type":21},"2031-12-30",{"name":240,"class":43},"Fundación GECP",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":114},"100222818","comprehensive-genomic-analysis-in-tissue-samples-from-patients-with-recurrent-or-stage-iv-non-small-cell-lung-cancer-100222818","NCT02178163","Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer","A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.","Inclusion Criteria:\n\n* Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor tissue for genomic analysis. Patients whose tumor has already undergone genomic analysis will be eligible.\n* Zubrod performance status 0-2\n* Life expectancy \\>= 3 months\n* Absolute neutrophil count of \\> 1.5 x 10\\^9\u002FL\n* Platelet count \\> 100,000 x 10\\^9\u002FL\n* Serum creatinine =\\\u003C 1.5 times the institutional upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft-Gault formula) of \\> 45 mL\u002Fmin\n* Serum bilirubin =\\\u003C 1.5 X ULN\n* Transaminases (serum glutamic oxaloacetic transaminase \\[SGOT\\] and\u002For serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 times institutional ULN and alkaline phosphatase =\\\u003C 2.5 times ULN, unless patient has liver metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases\n* Laboratory tests should be done within 30 days of enrollment on the trial\n* A biopsy of the patient's tumor for genomic profiling is required; this biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received systemic therapy since the biopsy has been obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site that has been radiated.\n* Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines\n\nExclusion Criteria:\n\n* Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient\n* Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible\n* Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy",{"count":249,"type":21},1020,[24],"This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid \\[DNA\\]) and help doctors to tailor treatment to target the specific mutations.",[253,63],"Recurrent Non-small Cell Lung Cancer","2025-07-22",{"date":256,"type":36},"2025-07-25",{"date":258,"type":36},"2014-08-01",{"date":260,"type":21},"2027-07",{"name":262,"class":43},"Barbara Ann Karmanos Cancer Institute",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":270,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":44},"100528952","analysis-of-circulating-tumor-dna-dynamics-to-predict-and-monitor-response-to-tki-in-patients-with-advanced-nsclc-100528952","NCT06167460","Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.","Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.\n* FFPE\u002FFNA sample is available.\n* Compliant with treatment protocol.\n* Patients consented to participate in the study.\n\nExclusion Criteria:\n\n* Patients already started TKI before enrollment.\n* Patients already started chemotherapy before enrollment.\n* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.\n* Patients did not agree to participate in the studies.",{"count":271,"type":21},50,"This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).\n\n1. Determine relationship between ctDNA dynamics and clinical response to TKI,\n\n   * No response\u002Fprogressive disease = ctDNA levels increase from baseline\n   * Partial response\u002Fstable disease = ctDNA levels decrease from baseline\n   * Complete response = ctDNA clearance.\n2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.\n3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.",[74,274,275,63,276],"Stage IIIB Non-small Cell Lung Cancer","Stage IIIC Non-Small Cell Lung Cancer","Tyrosine Kinase Inhibitors",[278,279,280],"Liquid Biopsy","Circulating Tumour DNA","Vietnam","2025-07-12",{"date":283,"type":36},"2025-07-16",{"date":285,"type":36},"2023-12-04",{"date":287,"type":21},"2025-12-01",{"name":289,"class":113},"Gene Solutions",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":44},"100342750","heterogeneously-hypofractionated-radiotherapy-for-locally-advanced-nsclc-100342750","NCT03742687","Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","Inclusion Criteria:\n\n* Histologically or cytological confirmed locally advanced, inoperable NSCLC.\n* Age ≥18 years.\n* Signed informed consent.\n* Performance status 0-2.\n* Able to comply with study and follow-up procedures.\n* Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter.\n\nExclusion Criteria:\n\n* Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.\n* Dose plan conforming to protocol planning criteria not possible.\n* Uncontrolled metastatic disease.\n* Other active malignant disease.",{"count":298,"type":21},151,[24],"The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment.\n\nThe aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).",[302,63,303],"Stage III Non-small-cell Lung Cancer","Radiotherapy Side Effect",[305,306,307],"Locally advanced NSCLC","Radiotherapy","Hypofractionation","2023-09-08",{"date":310,"type":36},"2023-09-11",{"date":312,"type":36},"2018-11-22",{"date":314,"type":21},"2026-12-30",{"name":316,"class":43},"Danish Lung Cancer Group"]