[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534667":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":47,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Camrelizumab Plus Chemotherapy Arm","EXPERIMENTAL","Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg\u002Fm2 or pemetrexed (for adenocarcinoma), 500mg\u002Fm2 plus platinum \\[cisplatin, 75 mg\u002Fm2; carboplatin, area under the curve, 5\\])",[13],"Drug: Camrelizumab Plus Chemotherapy",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Camrelizumab Plus Chemotherapy",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xue Meng, MD, PhD","CONTACT","+86-17653115602","mengxue5409@163.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Guoxin Cai, MD","+33-751440039","Guoxin.CAI@gustaveroussy.fr",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Jinan","Shandong","250117","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.99722,36.66833,{"lat":42,"lon":41},[45,46],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Xue Meng","MD, PhD","100534667","phase-2-neoadjuvant-camrelizumab-combined-with-chemotherapy-for-resectable-stage-iiia-iiib-nsclc-100534667",false,"NCT06241807","Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC","A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75\n* Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC\n* Absence of EGFR, ALK, and ROS1 gene mutations\n* Eastern Cooperative Oncology Group (ECOG) status 0-1\n* Signed written informed consent prior to the implementation of any trial-related rocedures\n* Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109\u002FL, Thrombocytes ≥ 100 х 109\u002FL, Hemoglobin ≥ 90 mg\u002FL, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL\u002Fmin, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \\> 5 x ULN, Bilirubin \\> 1.5 х ULN\n\nExclusion Criteria:\n\n* Patients diagnosed with any other malignant tumor\n* Have received prior therapy with chemotherapy or immune checkpoint inhibitor\n* Insufficient caloric and\u002For fluid intake despite consultation with a dietitian and\u002For tube feeding\n* Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment\n* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction\n* A history of interstitial lung disease or non-infectious pneumonia\n* Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years\n* Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibody) and various viral hepatitis infections\n* Patients who have received allogeneic stem cell or solid organ transplantation\n* Women during pregnancy or lactation","ALL","18 Years","75 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET\u002FCT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.",[69,70,71,72],"IMMUNOTHERAPY","Neoadjuvant Therapy","Resectable Lung Non-Small Cell Carcinoma","Biomarkers \u002F Blood",[74,75,70,76],"Camrelizumab","Non-Small Cell Lung Cancer","Biomarkers Analysis","2024-02-12",{"date":79,"type":80},"2024-02-14","ACTUAL",{"date":82,"type":80},"2022-12-02",{"date":84,"type":63},"2026-12-31",{"name":5,"class":6},1]