D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure
研究单位:[1]Chia Tai Tianqing Pharmaceutical Group Co., Ltd.[2]Anhui Province Hospital,Hefei,Anhui,China,230002[3]Cancer Hospital Chinese Academy of Medical Sciences,Beijing,Beijing,China,100021[4]Xuanwu Hospital Capital Medical University,Beijing,Beijing,China,100053[5]Beijing Cancer Hospital,Beijing,Beijing,China,100142[6]Peking University Third Hospital,Beijing,Beijing,China,100191[7]Beijing Chest Hospital,Capital Medical University,Beijing,Beijing,China,101149[8]The Fifth medical center of Chinese PLA General Hospital,Beijing,Beijing,China,222002[9]The Second Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China,400010[10]Chongqing Cancer Hospital,Chongqing,Chongqing,China,400032[11]The Southwest hospital of AMU,Chongqing,Chongqing,China,400038[12]Army Medical Center,Chongqing,Chongqing,China,400042[13]Chongqing University Three Gorges Hospital,Chongqing,Chongqing,China,404100[14]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350001[15]The First Affiliated Hospital Of Fujian Medical University,Fuzhou,Fujian,China,350005[16]Fujian Cancer Hospital,Fuzhou,Fujian,China,350500[17]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003[18]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730030[19]Gansu Provincial Cancer Hospital,Lanzhou,Gansu,China,730050[20]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510399[21]The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong,China,528405[22]The Affiliated Hospital of Guangdong Medical University,Zhanjiang,Guangdong,China,524001[23]The Second Affiliated Hospital of Guilin Medical College,Guilin,Guangxi,China,541199[24]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,530020[25]Yulin First People's Hospital,Yulin,Guangxi,China,537000[26]Guizhou Provincial People's Hospital,Guiyang,Guizhou,China,550002[27]The Second Affiliated Hospital of Zunyi Medical University,Zunyi,Guizhou,China,563000[28]Hainan Provincial People's Hospital,Haikou,Hainan,China,570311[29]Affiliated Hospital of Hebei University,Baoding,Hebei,China,050031[30]The Affiliated Hospital of Chengde Medical College,Chengde,Hebei,China,067028[31]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050011[32]Tangshan People's Hospital,Tangshan,Hebei,China,063001[33]Affiliated Cancer Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150000[34]The Second Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150000[35]Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital),Jiamusi,Heilongjiang,China,154000[36]Anyang Tumor Hospital,Anyang,Henan,China,455001[37]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,Henan,China,471003[38]Nanyang second general hospital,Nanyang,Henan,China,473000[39]The First affiliated Hospital of Nanyang Medical College,Nanyang,Henan,China,473007[40]The First Affiliated Hospital Of Xinxiang Medical Unerversity,Xinxiang,Henan,China,453100[41]Xuchang Central Hospital,Xuchang,Henan,China,461000[42]Henan Cancer Hospital,Zhengzhou,Henan,China,450008[43]The First Affiliated Hospital Zhejiang University School of Medicine,Zhengzhou,Henan,China,450052[44]Henan Provincial People's Hospita,Zhengzhou,Henan,China,463599[45]Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology,Wuhan,Hubei,China,430030[46]Zhongnan hospital of Wuhan University,Wuhan,Hubei,China,430071[47]The Second Xiangya Hospital Of Central South University,Changsha,Hunan,China,410011[48]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China,410013[49]Hunan Cancer Hospital,Changsha,Hunan,China,410031[50]Hunan Cancer Hospital,Changsha,Hunan,China,410031[51]Xiangya Hospital Central South University,Changsha,Hunan,China,410119[52]The first people's hospital of Changzhou,Changzhou,Jiangsu,China,213004[53]General Hospital of eastern theater command,Nan
研究目的:
The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.