[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100557432","prospective-non-interventional-study-comparing-osimertinib---chemotherapy-for-egfr-mutated-nsclc-patients-100557432",false,"NCT06538038","Prospective Non-Interventional Study Comparing Osimertinib +\u002F- Chemotherapy for EGFR-Mutated NSCLC Patients","Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +\u002F- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients","Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).\n* Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)\u002FInternational Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.\n* Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.\n* Prior chemotherapy and\u002For immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.\n* Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).\n* Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy\u002Fimmunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.\n* Patients that have received prior radiation therapy in any setting for this disease are eligible.\n* Adults age ≥ 18 years.","ALL","18 Years",{"count":19,"type":20},538,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.",[25,26,27,28],"Non Small Cell Lung Cancer","Epidermal Growth Factor Receptor Gene Mutation","Stage III Lung Cancer","Stage IV Lung Cancer",[30,31,32,33,34],"Osimertinib","Cisplatin","Carboplatin","Pemetrexed","EGFR Mutated","RECRUITING","2026-03-26",{"date":38,"type":39},"2026-03-27","ACTUAL",{"date":41,"type":39},"2024-09-17",{"date":43,"type":20},"2029-08",{"name":45,"class":46},"PrECOG, LLC.","OTHER",146,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100583588","phase-2-post-operative-radiotherapy-after-neodjuvant-chemo-immunotherapy-and-surgery-in-stage-iii-nsclc-100583588","NCT06878274","Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC","Radiotherapy to Optimize Event-free Survival Following Chemo-Immunotherapy and Surgery in Upper Stage III NSCLC With Evidence of Pathological Residual Disease (RESCUE): Phase II Trial","RESCUE","Inclusion Criteria:\n\n1. Participants must be ≥ 18 years old\n2. Ability to provide written informed consent\n3. ECOG performance status 0-2\n4. Histologically confirmed NSCLC\n5. Absence of actionable driver mutation (EGFR\u002FALK\u002FROS)\n6. Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory.\n7. Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3\n8. Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used.\n9. Status post-complete (R0) surgical resection with mediastinal lymph node dissection.\n10. Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response).\n11. Postoperative lung function examination: FEV1 \\> 1 L (or greater than 35% expected value)\n\nExclusion Criteria:\n\n1. Pregnant individuals\n2. Previous chest radiotherapy\n3. \\>24 weeks after thoracic surgery\n4. History of other non-cutaneous neoplasms within the last 24 months\n5. Active grade ≥ 2 pneumonitis.\n6. Presence of interstitial lung disease\n7. Recurrence or metastasis occurred\n8. Medical conditions that hinders the safe administration of radiotherapy or follow-up.",{"count":57,"type":20},118,"INTERVENTIONAL",[60],"PHASE2","This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.",[25,27],[64,65,66,67,68],"Post operative radiotherapy","lung cancer","non small cell lung cancer","stage III lung cancer","neoadjuvant immunotherapy","2026-02-07",{"date":71,"type":39},"2026-02-10",{"date":73,"type":39},"2026-01-29",{"date":75,"type":20},"2032-02",{"name":77,"class":46},"Centre hospitalier de l'Université de Montréal (CHUM)",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":78},"100477799","phase-1-split-course-adaptive-radiation-therapy-with-pembrolizumab-withwithout-chemotherapy-for-treating-stage-iv-lung-cancer-100477799","NCT05501665","Split Course Adaptive Radiation Therapy With Pembrolizumab With\u002FWithout Chemotherapy for Treating Stage IV Lung Cancer","SiCARIO (Split Course Adaptive Radioimmunotherapy) for the Treatment of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Using Biologically-Adaptive Radiotherapy - A Phase I\u002FII Study","Inclusion Criteria:\n\n* Age \\>= 18 years at time of informed consent\n* • Histologically documented or cytologically confirmed diagnosis of stage IVA or IVB (M1b or M1c) or locally advanced (not eligible for standard of care \\[SOC\\] chemoradiation) non-small cell lung cancer with evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria\n* Available tumor material (\\\u003C 6 months old) adequate for confirmation of programmed cell death 1 ligand 1 (PD-L1) expression per local standard of care testing\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function to receive therapy as determined by investigators and other treating physicians\n* Participants with brain metastases that can be comprehensively managed with surgery and\u002For stereotactic radiosurgery, prior to initiation of chemo-immunotherapy are allowed. Number of brain metastases allowed is not specified at eligibility is at discretion of investigator\n* Contraceptive use should be initiated or continued per guidance in labeling for approved chemotherapies\n* Female patients must be non-pregnant and not breastfeeding.\n\n  * If woman of childbearing potential (WOCBP), must utilize highly effective contraceptive method (failure rate of \\\u003C 1% per year) throughout intervention period and continued per guidance specified in labeling for approved chemotherapies. Must have negative pregnancy test (serum or urine) within 1 week prior to initiation of first cycle of therapy\n* Eligible for immunotherapy-based systemic regimens per judgment of patient's study physician\n* Able to submit written informed consent\n\nExclusion Criteria:\n\n* Mixed small cell histology\n* Confirmed candidate (per study physician) for alternative systemic therapy if preferred by treating physician (i.e. mEGFR, ALK, KRAS G12C or ROS1 mutations). Testing not required for enrollment\n* Brain metastases that would require administration of whole brain radiotherapy for management on required screening brain MRI within 21 days of day 1 of study treatment\n* Symptomatic malignant ascites or malignant pleural effusion (sampling not required). Pleural metastases are allowed if deemed targetable with radiotherapy\n* Major surgery (requiring general anesthesia or at discretion of study physician) within 4 weeks prior to study enrollment that would prevent treatment with SiCARIO regimen\n* History of organ transplant requiring therapeutic immunosuppression\n* Known clinically significant (per study physician) acute or chronic infections including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis (testing not required). Patients with HBV and HCV must be on stable dose of antiviral therapy on study entry\n* Uncontrolled intercurrent illness including, but not limited to, New York Heart Association (NYHA) class III-IV congestive heart failure, uncontrolled hypertension (average systolic blood pressure greater than or equal to 140 or average diastolic blood pressure greater than or equal to 90 despite optimal medical therapy), unstable angina pectoris, cardiac arrythmia, active peptic ulcer disease, bleeding diatheses or psychiatric illness that would limit in the judgment of the study physician\n* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of day 1 of study treatment\n* History of prior independent malignancy within 3 years of enrollment, except for adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g. cervix or non-invasive bladder cancer)\n* Receipt of prior \\>1 cycle of immune checkpoint inhibitor for current malignancy (prior cytotoxic chemotherapy is allowed)\n* Prior radiotherapy that would preclude delivery of protocol- based radiotherapy to normal organ tolerance per patient's study physician\n* Current or prior use of immunosuppressive medications within 28 days of enrollment with exception of intranasal or inhaled corticosteroids or systemic steroids at physiologic doses (equivalent to less than or equal to 10 mg\u002Fday of prednisone). Systemic steroids required during therapy for adverse event (AE) management and for residual neurologic complications from management of central nervous system (CNS) metastases are allowed at doses exceeding 10 mg\u002Fday of prednisone equivalents\n* Active autoimmune disease requiring systemic treatment within past 1 year\n* Receipt of live attenuated vaccine within 30 days of enrollment\n* Use of prohibited concomitant drug within 30 days of enrollment\n* Known severe (\\>= grade 3 Common Terminology Criteria for Adverse Events \\[CTCAE\\]) hypersensitivity to study intervention or formulation\n* Concurrent enrollment in another clinical trial (unless observational or within follow-up period)\n* Any condition at discretion of investigator that will preclude participation in the study",{"count":87,"type":20},25,[89,60],"PHASE1","This phase I\u002FII trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab 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 like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.",[92,93,27],"Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8",[95,96,97],"Oligometastasis","Adaptive Radiotherapy","Immunotherapy","2024-10-16",{"date":100,"type":39},"2024-10-17",{"date":102,"type":39},"2023-05-09",{"date":104,"type":20},"2027-02-01",{"name":106,"class":46},"Vanderbilt-Ingram Cancer Center"]