研究单位:[1]Jiangsu HengRui Medicine Co., Ltd.[2]The Second Affiliated Hospital Of Anhui Medical University Hefei, Anhui, China, 230036[3]Anhui Chest Hospital Hefei, Anhui, China, MD[4]Beijing Cancer Hospital Beijing, Beijing, China, 100000[5]The Fifth Medical Center of PLA Ceneral Hospital Beijing, Beijing, China, 100000[6]The Seventh Medical Center of PLA Ceneral Hospital Beijing, Beijing, China, 100000[7]Beijing Cancer Hospital Beijing, Beijing, China, 100142[8]Chongqing University Cancer Hospital Chongqing, Chongqing, China, 400030[9]900TH Hospital of Joint Logistics Support Force Fuzhou, Fujian, China, 350001[10]Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou, Guangdong, China, 510095[11]The First Affiliated Hospital of Guangzhou Medical University Guangzhou, Guangdong, China, 510120[12]Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China, 510515[13]Jieyang People's Hospital Jieyang, Guangdong, China, 522000[14]Affiliated Hospital of Zunyi Medical University Zunyi, Guizhou, China, 563003[15]Affiliated Hospital of Chengde Medical College Chengde, Hebei, China, 067000[16]The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital) Shijiazhuang, Hebei, China, 50000河北医科大学第四医院[17]Tangshan People's Hospital Tangshan, Hebei, China, 63001[18]Harbin Medical University Cancer Hospital Harbin, Heilongjiang, China, 150000[19]Henan Cancer Hospital Zhengzhou, Henan, China, 450000[20]The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450000[21]Henan Provincial People's Hospital Zhengzhou, Henan, China, 450003[22]Hubei Cancer Hospital Wuhan, Hubei, China, 430000[23]Tongji Hospital, Tongji Medical College of Hust Wuhan, Hubei, China, 430000[24]Xiang yang Central Hospital Xiangyang, Hubei, China, 441000[25]Hunan Cancer Hospital Changsha, Hunan, China, 410006[26]The Second Xiangya Hospital Of Central South University Changsha, Hunan, China, 410008[27]The Third Xiangya Hospital Of Central South University Changsha, Hunan, China, 410013[28]Jiangsu Province Hospital Nanjing, Jiangsu, China, 210000[29]Nanjing Drum Tower Hospital Nanjing, Jiangsu, China, 210008[30]Affiliated Hospital of Jiangnan University Wuxi, Jiangsu, China, 214122[31]Northern Jiangsu People's Hospital Yangzhou, Jiangsu, China, 225001[32]Jiangxi Cancer Hospital Nanchang, Jiangxi, China, 330006[33]The First Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China, 330006[34]China-Japan Union Hospital of Jilin University Changchun, Jilin, China, 130012[35]Jilin Cancer Hospital Changchun, Jilin, China, 130012[36]The First Bethune Hospital of Jilin University Changchun, Jilin, China, 130012[37]The First Hospital of China Medical University Shenyang, Liaoning, China, 110001[38]Jinan Central Hospital Jinan, Shandong, China, 250013[39]LinYi Cancer Hospital Linyi, Shandong, China, 276001[40]Shanghai Changhai Hospital Shanghai, Shanghai, China, 200433[41]Shanghai Pulmonary Hospital, Tongji University Shanghai, Shanghai, China, 200433[42]Baoji Central Hospital Baoji, Shanxi, China, 721000[43]Heping Hospital Affiliated to Changzhi Medical College Changzhi, Shanxi, China, 046000[44]Shanxi Provincial People's Hospital Taiyuan, Shanxi, China, 030000[45]Shaanxi Provincial Cancer Hospital Xian, Shanxi, China, 710061[46]Sichuan Provincial Cancer Hospital Chengdu, Sichuan, China, 610000[47]Tianjin Medical University Cancer Institute and Hospital Tianjin, Tianjin, China, 300060[48]Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Kunming, Yunnan, China, 650118[49]The First Affiliated Hospital,ZheJiang University Hangzhou, Zhejiang, China, 310003[50]Sir Run Run Shaw Hospital ZheJiang University School Of Medicine Hangzhou, Zhejiang, China, 310018[51]ZheJiang Cancer Hospital HangZhou, Zhejiang, China, 310022[52]The Second Affiliated Hospital of Zhejiang University of Medicine Hangzhou, Zhejiang, China, 310052[53]Taizhou Hospital of Zhejiang Province Taizhou, Zhejiang, China, 317000[54]Anhui Provincial Hospital Hefei, Anhui, China, 230036
研究目的:
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.