[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613289":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":65,"collaborators":27,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":27,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":27,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Fondazione Ricerca Traslazionale","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"surgery","EXPERIMENTAL","After a neoadjuvant chemoimmuno treatment patient is selected to the surgery and immuno maintenance arm if resectable",[13,14],"Drug: Tislelizumab","Procedure: surgery (any volume) and \u002F or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines",{"label":16,"type":17,"description":18,"interventionNames":19},"chemoradio","ACTIVE_COMPARATOR","After neoadjuvant chemoimmuno treatment patient is selected to surgery and immuno maintenance arm if resectable",[13,20],"Radiation: Chemoradiotherapy",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tislelizumab","Compared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno",[16,9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","surgery (any volume) and \u002F or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines","surgery if resectable after neoadjuvant treatment",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"RADIATION","Chemoradiotherapy","if patient not resectable after neoadjuvant treatment, chemoradiotherapy performed",[16],[39],{"name":40,"affiliation":41,"role":42},"Federico Cappuzzo","Istituti Fisioterapici Ospitalieri","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":27,"email":48},"Federico Cappuzzo, Medical Oncology","CONTACT","+390652665789","federico.cappuzzo@fondazionefort.org",[50],{"facility":41,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Rome","Roma (RM)","00144","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],12.51133,41.89193,{"lat":61,"lon":60},[64],{"name":45,"role":46,"phone":47,"phoneExt":27,"email":48},{"type":66,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100613289","phase-2-neoadjuvant-chemo-immunotherapy-for-stage-iii-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100613289",false,"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.","ALL","18 Years","99 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","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).",[84],"Stage III NSCLC","2025-11-24",{"date":87,"type":88},"2025-12-04","ACTUAL",{"date":90,"type":88},"2025-03-27",{"date":92,"type":78},"2030-02-01",{"name":5,"class":6},1]