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A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

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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 [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.

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