[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567358":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":47,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fundação Faculdade Regional de Medicina de São José do Rio Preto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose nivolumab combined with platinum-based doublet chemotherapy","EXPERIMENTAL",null,[13],"Drug: Low-dose nivolumab combined with platinum-based doublet chemotherapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg\u002Fm² or pemetrexed at 500 mg\u002Fm²), administered with nivolumab at 0.3 mg\u002Fkg every 21 days for 3 cycles.",[9],[20],{"name":21,"affiliation":22,"role":23},"JOAO A SOLER, MD","FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},"CONTACT","+55 17 981350180","joao.soler@hbonco.org.br",{"name":30,"role":26,"phone":11,"phoneExt":11,"email":31},"ALINE FARES, MD","aline.fares@edu.famerp.br",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto","RECRUITING","São José do Rio Preto","São Paulo","15090000","Brazil","BR",{"type":42,"coordinates":43},"Point",[44,45],-49.37944,-20.81972,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Aline Fusco Fares, MD","MD",[52],{"name":53,"class":6},"Hospital de Base","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":64,"type":65},33,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71,72],"Lung Cancer, Nonsmall Cell","Non-Small Cell Lung Cancer NSCLC",[74,75,76],"Low Dose Immunotherapy","Neoadjuvant immunotherapy","Non-Small-Cell-Lung-Cancer","2024-10-29",{"date":79,"type":80},"2024-10-31","ACTUAL",{"date":82,"type":80},"2023-10-10",{"date":84,"type":65},"2027-10-31",{"name":49,"class":6},1]