[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aline Fusco Fares, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100567358","phase-2-efficacy-analysis-of-neoadjuvant-treatment-in-lung-cancer-using-low-dose-nivolumab-combined-with-chemotherapy-100567358",false,"NCT06667154","Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy","Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy","Inclusion Criteria:\n\n* Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.\n* Male or female, aged 18 years or older.\n* Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.\n* Receiving treatment at Hospital de Base.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.\n* Tumor sample meets the following requirements:\n* Negative for EGFR gene expression.\n* Negative for ALK and ROS1 protein expression.\n* PD-L1 protein expression documented and assessable.\n* Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.\n* Adequate organ and bone marrow function as defined below:\n* Hemoglobin: ≥ 9.0 g\u002FdL\\*\n* Absolute neutrophil count: ≥ 1.5 × 10\\^9 \u002FL\\*\n* Platelet count: ≥ 100 × 10\\^9 \u002FL\\*\n* \\*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.\n* Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.\n* ALT and AST: ≤ 2.5 × ULN.\n* Creatinine clearance: ≥ 50 mL\u002Fmin (calculated using the Cockcroft and Gault formula).\n* Life expectancy greater than six months prior to randomization.\n\nExclusion Criteria:\n\n* Refusal to sign the Informed Consent Form (ICF).\n* NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.\n* Tumors with T4 invasion of the aorta, esophagus, and\u002For heart; or presence of bulky N2 disease.\n* Tumor deemed unresectable.\n* Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.\n* History of another primary malignancy, with exceptions for:\n* Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.\n* Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.\n* Adequately treated carcinoma in situ with no evidence of disease.\n* Incomplete basic medical information in the electronic medical record.\n* Positive for EGFR gene expression.\n* Positive for ALK protein expression.\n* No available data on PD-L1 protein expression.\n* Positive for ROS1 protein expression.\n* Pregnant or breastfeeding at the time of enrollment.","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.",[26,27],"Lung Cancer, Nonsmall Cell","Non-Small Cell Lung Cancer NSCLC",[29,30,31],"Low Dose Immunotherapy","Neoadjuvant immunotherapy","Non-Small-Cell-Lung-Cancer","RECRUITING","2024-10-29",{"date":35,"type":36},"2024-10-31","ACTUAL",{"date":38,"type":36},"2023-10-10",{"date":40,"type":20},"2027-10-31",{"name":42,"class":43},"Aline Fusco Fares, MD","OTHER",""]