研究单位：[1]Shanghai Pulmonary Hospital, Shanghai, China[2]Dizal Pharmaceuticals[3]Beijing Cancer Hospital,Beijing,China[4]Beijing Chest Hospital, Capital Medical University,Beijing,China[5]Cancer Hospital of the Chinese Academy of Medical Sciences,Beijing,China[6]Peking Union Medical College Hospital,Beijing,China[7]Peking University Third Hospital,Beijing,China[8]Hunan Cancer Hospital,Changsha,China[9]West China Hospital of Sichuan University,Chengdu,China[10]Army Medical Center of PLA,Chongqing,China[11]Chongqing Cancer Hospital,Chongqing,China[12]Fujian Cancer Hospital,Fuzhou,China[13]Fujian Medical University Union Hospital,Fuzhou,China[14]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou,China[15]The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,China[16]Harbin Medical University Cancer Hospital,Ha''erbin,China[17]The First Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,China[18]Zhejiang Cancer Hospital,Hangzhou,China[19]Anhui Provincial Hospital,Hefei,China[20]The First Affiliated Hospital of Anhui Medical University,Hefei,China[21]The Affiliated Hospital of Inner Mongolia Medical University,Hohhot,China[22]Jilin Cancer Hospital,Jilin,China[23]Central Hospital Affiliated to Shandong First Medical University,Jinan,China[24]Shandong Cancer Hospital & Institution,Jinan,China[25]Yunnan Cancer Hospital,Kunming,China[26]The Second Affiliated Hospital of Nanchang University,Nanchang,China[27]Jiangsu Cancer Hospital,Nanjing,China[28]Jiangsu Provincial Hospital,Nanjing,China[29]Guangxi Medical University Cancer Hospital,Nanning,China[30]Shanghai Chest Hospital,Shanghai,China[31]Shanghai Pulmonary Hospital,Shanghai,China[32]ZhongShan Hospital Fudan University,Shanghai,China[33]The First Hospital of China Medical University,Shenyang,China[34]The Fourth Hospital of Hebei Medical University,Shijiazhuang,China[35]Shanxi Provincial Cancer Hospital,Taiyuan,China[36]Taizhou Hospital of Zhejiang Province,Taizhou,China[37]Tianjin Medical University Cancer Institute & Hospital,Tianjin,China[38]Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology,Wuhan,China[39]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan,China[40]The First Affiliated Hospital of Xi ''an Jiaotong University,Xi''an,China[41]Yantai Yuhuangding Hospital,Yantai,China[42]Henan Cancer Hospital,Zhengzhou,China[43]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China
研究目的：
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
