A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC
研究单位：[1]Shanghai Henlius Biotech[2]Oncology and Hematology Associates of Southwest Virginia,Roanoke,Virginia,United States,24014[3]Anhui Medical University - The Second Hospital,Hefei,Anhui,China[4]Anhui Provincial Hospital,Hefei,Anhui,China[5]The First Affiliated Hospital Of Anhui Medical University,Hefei,Anhui,China[6]The Second Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China[7]Beijing Chaoyang Hospital,Beijing,Beijing,China[8]Beijing Friendship Hospital,Beijing,Beijing,China[9]Peking University First Hospital,Beijing,Beijing,China[10]Daping Hospital,Chongqing,Chongqing,China[11]The Second Affiliated Hospital of Army Medical University,PLA,Chongqing,Chongqing,China[12]Fujian Medical University Union Hospital,Fuzhou,Fujian,China[13]Fujian Provincial Cancer Hospital,Fuzhou,Fujian,China[14]Fuzhou Pulmonary hospital of Fujian,Fuzhou,Fujian,China[15]Gansu Wuwei Tumour Hospital,Wuwei,Gansu,China[16]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China[17]The Fifth Affiliared Hospital Sun Yat-Sen University,Zhuhai,Guangdong,China[18]Liuzhou People's Hospital,Liuzhou,Guangxi,China[19]Liuzhou Worker's Hospital,Liuzhou,Guangxi,China[20]Guangxi Medical University Affiliated Tumor Hospital,Nanning,Guangxi,China[21]The People's Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China[22]The Second Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China[23]Affiliated Hospital of Hebei University,Baoding,Hebei,China[24]Cangzhou People's Hospital,Cangzhou,Hebei,China[25]Tangshan People's Hospital,Tangshan,Hebei,China[26]Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital),Ha'erbin,Heilongjiang,China[27]The fourth affiliated hospital of Harbin medical university,Ha'erbin,Heilongjiang,China[28]Jiamusi Cancer Hospital,Jiamusi,Heilongjiang,China[29]The Third Affiliated Hospital of Qiqihar Medical University,Qiqihar,Heilongjiang,China[30]The First Affiliated Hospital of Xinxiang Medical University,Xinxiang,Henan,China[31]Henan Cancer Hospital,Zhengzhou,Henan,China[32]Hubei Cancer Hospital,Wuhan,Hubei,China[33]Hunan Cancer Hospital,Changsha,Hunan,China[34]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China[35]Xuzhou Central Hospital,Xuzhou,Jiangsu,China[36]the First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[37]China-japan union hospital of jilin university,Changchun,Jilin,China[38]Jilin Province Cancer Hospital,Changchun,Jilin,China[39]Jilin Province People's Hospital,Changchun,Jilin,China[40]The first hospital of Jilin University,Changchun,Jilin,China[41]The second Hospital of Jilin University,Changchun,Jilin,China[42]Chifeng Municipal Hospital,Chifeng,Neimenggu,China[43]General Hospital of Ningxia Medical University,Yinchuan,Ningxia,China[44]Shandong Cancer Hospital - Internal Medicine,Jinan,Shandong,China[45]Linyi City People Hospital,Linyi,Shandong,China[46]Shandong Linyi Tumor Hospital,Linyi,Shandong,China[47]Shanghai Eastern Hospital /Affliated Eastern Hospital of Ton,Shanghai,Shanghai,China[48]Shanghai Pulmonary Hospital,Shanghai,Shanghai,China[49]West China Hospital, Sichuan University,Chengdu,Sichuan,China[50]Tianjin Medical University Cancer Hospital,Tianjin,Tianjin,China[51]Tianjin Medical University General Hospital,Tianjin,Tianjin,China[52]Yunnan cancer hospital,Kunming,Yunnan,China[53]Sir Run Run Shaw Hospital, Zhejiang University,Hangzhou,Zhejiang,China[54]The First Affiliated Hospital of Zhejiang University,Hangzhou,Zhejiang,China[55]The Second Affiliated Hospital of Zhejiang University,Hangzhou,Zhejiang,China[56]High Technology Hospital MedCenter LTD,Batumi,Georgia[57]JSC Evex Clinics, St.Nikolozi Medical Centre,Kutaisi,Georgia[58]Acad.F.Todua Medical Center - Research Institute of Clinical Medicine LTD,Tbilisi,Georgia[59]Institute of Clinical Oncology LTD,Tbilisi,Georgia[60]LTD Israeli-Georgian Medical Research Clinic HELSICORE,Tbilisi,Georgia[61]Multiprofile
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or metastatic squamous NSCLC who have not previously received systemic treatment. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (carboplatin nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores [TPS]≥50%, 50%>TPS≥1%, TPS<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).
