研究单位:[1]Tongji University, Shanghai Pulmonary Hospital[2]Jiangsu HengRui Medicine Co., Ltd.[3]Anhui Provincial Hospital,Hefei,Anhui,China,230036[4]The Second Affiliated Hospital Of Anhui Medical University,Hefei,Anhui,China,230036[5]Anhui Chest Hospital,Hefei,Anhui,China,MD[6]Beijing Cancer Hospital,Beijing,Beijing,China,100000[7]The Fifth Medical Center of PLA Ceneral Hospital,Beijing,Beijing,China,100000[8]The Seventh Medical Center of PLA Ceneral Hospital,Beijing,Beijing,China,100000[9]Beijing Cancer Hospital,Beijing,Beijing,China,100142[10]Chongqing University Cancer Hospital,Chongqing,Chongqing,China,400030[11]900TH Hospital of Joint Logistics Support Force,Fuzhou,Fujian,China,350001[12]Affiliated Cancer Hospital and Institute of Guangzhou Medical University,Guangzhou,Guangdong,China,510095[13]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China,510120[14]Nanfang Hospital, Southern Medical University,Guangzhou,Guangdong,China,510515[15]Jieyang People''s Hospital,Jieyang,Guangdong,China,522000[16]Affiliated Hospital of Zunyi Medical University,Zunyi,Guizhou,China,563003[17]Affiliated Hospital of Chengde Medical College,Chengde,Hebei,China,067000[18]The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital),Shijiazhuang,Hebei,China,50000[19]Tangshan People''s Hospital,Tangshan,Hebei,China,63001[20]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China,150000[21]Henan Cancer Hospital,Zhengzhou,Henan,China,450000[22]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450000[23]Henan Provincial People''s Hospital,Zhengzhou,Henan,China,450003[24]Hubei Cancer Hospital,Wuhan,Hubei,China,430000[25]Tongji Hospital, Tongji Medical College of Hust,Wuhan,Hubei,China,430000[26]Xiang yang Central Hospital,Xiangyang,Hubei,China,441000[27]Hunan Cancer Hospital,Changsha,Hunan,China,410006[28]The Second Xiangya Hospital Of Central South University,Changsha,Hunan,China,410008[29]The Third Xiangya Hospital Of Central South University,Changsha,Hunan,China,410013[30]Jiangsu Province Hospital,Nanjing,Jiangsu,China,210000[31]Nanjing Drum Tower Hospital,Nanjing,Jiangsu,China,210008[32]Affiliated Hospital of Jiangnan University,Wuxi,Jiangsu,China,214122[33]Northern Jiangsu People''s Hospital,Yangzhou,Jiangsu,China,225001[34]Jiangxi Cancer Hospital,Nanchang,Jiangxi,China,330006[35]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330006[36]China-Japan Union Hospital of Jilin University,Changchun,Jilin,China,130012[37]Jilin Cancer Hospital,Changchun,Jilin,China,130012[38]The First Bethune Hospital of Jilin University,Changchun,Jilin,China,130012[39]The First Hospital of China Medical University,Shenyang,Liaoning,China,110001[40]Jinan Central Hospital,Jinan,Shandong,China,250013[41]LinYi Cancer Hospital,Linyi,Shandong,China,276001[42]Shanghai Changhai Hospital,Shanghai,Shanghai,China,200433[43]Shanghai Pulmonary Hospital, Tongji University,Shanghai,Shanghai,China,200433[44]Baoji Central Hospital,Baoji,Shanxi,China,721000[45]Heping Hospital Affiliated to Changzhi Medical College,Changzhi,Shanxi,China,046000[46]Shanxi Provincial People''s Hospital,Taiyuan,Shanxi,China,030000[47]Shaanxi Provincial Cancer Hospital,Xian,Shanxi,China,710061[48]Sichuan Provincial Cancer Hospital,Chengdu,Sichuan,China,610000[49]Tianjin Medical University Cancer Institute and Hospital,Tianjin,Tianjin,China,300060[50]Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center,Kunming,Yunnan,China,650118[51]The First Affiliated Hospital,ZheJiang University,Hangzhou,Zhejiang,China,310003[52]Sir Run Run Shaw Hospital ZheJiang University School Of Medicine,Hangzhou,Zhejiang,China,310018[53]ZheJiang Cancer Hospital,HangZhou,Zhejiang,China,310022[54]The Second Affiliated Hospital of Zhejiang University of Medicine,Hangzhou,Zhejiang,China,310052[55]Taizhou Hospital
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.