[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437209":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":38,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":38,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":38,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":47,"whyStopped":38,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant treatment","EXPERIMENTAL","Participants will receive 4 doses of sintilimab (200 mg, IV) and bevacizumab (15 mg\u002Fkg, IV) every 3 weeks (Q3W). Participants will also receive 4 doses of carboplatin (AUC=5, IV) and pemetrexed (500 mg\u002Fm2, IV) Q3W.\n\nSurgery will be performed within 4 to 6 weeks after completion of preoperative therapy.\n\nAfter the second dose of sintilimab, bevacizumab and chemotherapy, contrast-enhanced chest CT will be performed. Patients with progression disease will receive surgery without the last 2 doses of treatment.",[13,14],"Drug: sintilimab","Drug: bevacizumab",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","sintilimab","Sintilimab 200 mg, 4 cycles of treatment before surgery",[9],[22,23],"IBI308","Xindili Dankang",{"type":17,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"bevacizumab","bevacizumab 15 mg\u002Fkg, 4 cycles of treatment before surgery",[9],[29],"Bei Fa Zhu Dankang Zhusheye",[31],{"name":32,"affiliation":5,"role":33},"Hecheng Li, MD, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","0086-021-64370045",null,"lihecheng2000@hotmail.com",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Yuyan Zheng, MD","0086-15280093677","yuyanzheng@outlook.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60,62,63],{"name":61,"role":36,"phone":37,"phoneExt":38,"email":39},"Hecheng Li, MD,PHD",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},{"name":61,"role":33,"phone":38,"phoneExt":38,"email":38},{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Hecheng Li M.D., Ph.D","Professor","100437209","preoperative-sintilimab-combined-with-bevacizumab-and-chemotherapy-for-resectable-non-small-cell-lung-cancer-100437209",false,"NCT04973293","Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer","The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;\n4. Patients approve and sign the informed consent.\n\nExclusion Criteria:\n\n1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;\n2. Patients with active autoimmune disease or history of autoimmune disease;\n3. Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;\n4. Patients with a history of symptomatic interstitial lung disease;\n5. History of allergy to study drug components;\n6. Women must not be pregnant or breast-feeding;\n7. Men with female partners that are not willing to use contraception;\n8. Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;\n9. Patients who have received prior treatment for non-small cell lung cancer;\n10. Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;\n11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;\n12. Patients with high risk of major bleeding;\n13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;\n14. Patients who have prior malignancies;\n15. HIV, HBV, HCV infection or active pulmonary tuberculosis;\n16. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.","ALL","18 Years","75 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"NA","Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1\u002FPD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.",[85],"Lung Neoplasm Malignant",[87,88,89],"Non-small cell lung cancer","Neoadjuvant therapy","Immunotherapy","2024-11-16",{"date":92,"type":93},"2024-11-19","ACTUAL",{"date":95,"type":93},"2022-10-01",{"date":97,"type":79},"2025-12-31",{"name":5,"class":6},1]