[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-nsclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100566547","phase-2-adjuvant-chemotherapy---cemiplimab-and-sequential-hypofractionated-radiotherapy-in-unfit-or-elderly-patients-with-stage-iii-lung-cancer-100566547",false,"NCT06656598","Adjuvant Chemotherapy +\u002F- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer","A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer","SPORADIC","Inclusion Criteria:\n\n1. Patients must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n2. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n3. Age ≥ 18 years.\n4. Histologically or cytologically confirmed locally advanced non small cell lung cancer (NSCLC) stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015.\n5. Patients over 70 years of age with Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS of 0 to 1.\n\n   Or Patients under 70 years of age with ECOG PS of 0 to 1 and a score ≥ 3 according to the Charlson comorbidity criterion or ECOG PS 2.\n6. Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.\n7. Measurable disease according to RECIST 1.1.\n8. Respiratory function:\n\n   * FEV1 ≥ 40% of theoretical value,\n   * DLCO ≥ 40%.\n9. Bone marrow function:\n\n   * absolute neutrophil count (ANC) ≥ 1.5.109\u002FL,\n   * platelets ≥ 100.109\u002FL,\n   * hemoglobin ≥ 9 g\u002Fdl.\n10. Renal and hepatic function:\n\n    * estimated creatinine clearance ≥ 45 ml\u002Fmin,\n    * bilirubin ≤1.5xULN,\n    * AST ALT ≤3xULN,\n    * Albumin ≥28g\u002Fdl.\n11. Participant has national health insurance coverage.\n12. Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential.\n\nExclusion Criteria:\n\n1. Immunotherapy or chemotherapy contra-indicated.\n2. Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.\n3. Stage I or II NSCLC.\n4. Previously received a treatment with anti-PD1\u002FPDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.\n5. Histology other than primary non-small cell lung cancer.\n6. Patients with an activating EGFR mutation or ALK or ROS1 translocation.\n7. Metastatic NSCLC including brain metastasis.\n8. Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met).\n9. Severe uncontrolled comorbidities or severe intercurrent disease: acute coronary syndrome less than 3 months old, unstable angina, heart failure with LVEF ≤30%, uncontrolled hypertension, Child B or C cirrhosis, severe sepsis, myocarditis or any other active conditions that would contraindicate chemotherapy, immunotherapy, or radiotherapy in the opinion of the investigator.\n10. Weight loss ≥15% of total body weight in the last 6 months.\n11. ECOG PS upper 2\n12. Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory bowel disease, vasculitis, sarcoidosis, uveitis. Autoimmune thyroid pathologies under replacement therapy as well as type 1 diabetes under insulin are authorized.\n13. History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan.\n14. Any immunosuppressive therapy received within 28 days and corticosteroids \\> 10mg\u002Fday of prednisone or equivalent received within 7 days prior the start of chemotherapy excepted hydrocortisone replacement for adrenal insufficiency or pituitary disease not considered immunosuppressive therapy.\n15. Chronic active infection including tuberculosis, HIV, hepatitis B (HBsAg positive) or C. Patients with a history of cured hepatitis B (anti HBc and absence of negative HBs antigen) are eligible. In case of hepatitis C (anti HCV Ac) patients are eligible if the HCV PCR is negative.\n16. Severe infections (including covid-19 infection) within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n17. History of neoplastic disease less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the uterus).\n18. History of thoracic radiotherapy.\n19. Live attenuated vaccine received within 28 days of starting chemotherapy\n20. History of organ or bone marrow transplantation.\n21. Major surgery within 4 weeks of starting treatment.\n22. Patient already included in another therapeutic trial.\n23. Positive pregnancy test or breastfeeding woman.\n24. Protected adults (under guardianship or curatorship).\n25. Inability to undergo medical monitoring of the study (for geographical, social and\u002For physical reasons).\n26. Patients unable to understand the study.","ALL","18 Years",{"count":20,"type":21},152,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.",[27],"Stage III NSCLC",[29,30,31,32],"NSCLC","NSCLC, Stage III","Unfit or elderly patients","IFCT","RECRUITING","2026-02-09",{"date":36,"type":37},"2026-02-11","ACTUAL",{"date":39,"type":37},"2025-11-07",{"date":41,"type":21},"2032-01",{"name":43,"class":44},"Intergroupe Francophone de Cancerologie Thoracique","OTHER",25,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100613289","phase-2-neoadjuvant-chemo-immunotherapy-for-stage-iii-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100613289","NCT07264647","Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Histologically confirmed stage III disease.\n\n  * PD-L1 TPS ≥ 1% according to local testing.\n  * No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.\n\nMandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.\n\n* Pulmonary function tests within 6 months of the planned resection.\n* At least 1 measurable lesion as defined by RECIST v1.1.\n* ECOG Performance Status ≤ 1.\n* Eligibility to receive a platinum doublet chemotherapy regimen.\n* Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug:\n\nPatients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:\n\nAbsolute neutrophil count ≥ 1.5 x 109 \u002FL Platelets ≥ 75 x 109 \u002FL Hemoglobin ≥ 90 g\u002FL Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9).\n\nFor patients intended to receive cisplatin: creatinine clearance 60mL\u002Fmin For patients intended to receive carboplatin: creatinine clearance 45mL\u002Fmin Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be \\\u003C 3 x ULN for patients with Gilberts syndrome).\n\nAST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN\n\n* Age ≥ 18 years.\n* Written informed consent.\n\nExclusion Criteria:\n\nEvidence of stage IV NSCLC (metastatic disease).\n\n* Histology of large cell neuroendocrine carcinoma (LCNEC).\n* Any previous therapy for current lung cancer, including chemotherapy or radiation therapy.\n* Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1.\n* Never smoking patients.\n* Active autoimmune diseases or history of autoimmune diseases that may recur.\n* Concomitant participation in another therapeutic clinical trial.\n* Pregnancy or breastfeeding.","99 Years",{"count":54,"type":21},30,[24],"A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC.\n\nAdults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).",[27],"2025-11-24",{"date":60,"type":37},"2025-12-04",{"date":62,"type":37},"2025-03-27",{"date":64,"type":21},"2030-02-01",{"name":66,"class":44},"Fondazione Ricerca Traslazionale",1]