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]Beijing Cancer Hospital,Beijing,Beijing,China,100142[4]Peking University Third Hospital,Beijing,Beijing,China,100191[5]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350001[6]The First Affiliated Hospital Of Fujian Medical University,Fuzhou,Fujian,China,350005[7]Fujian Cancer Hospital,Fuzhou,Fujian,China,350500[8]Gansu Provincial Cancer Hospital,Lanzhou,Gansu,China,730050[9]The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong,China,528405[10]The Affiliated Hospital of Guangdong Medical University,Zhanjiang,Guangdong,China,524001[11]The Second Affiliated Hospital of Guilin Medical College,Guilin,Guangxi,China,541199[12]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,530020[13]Guizhou Provincial People''s Hospital,Guiyang,Guizhou,China,550002[14]Hainan Provincial People''s Hospital,Haikou,Hainan,China,570311[15]Affiliated Hospital of Hebei University,Baoding,Hebei,China,050031[16]The Affiliated Hospital of Chengde Medical College,Chengde,Hebei,China,067028[17]Affiliated Cancer Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150000[18]The Second Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150000[19]Anyang Tumor Hospital,Anyang,Henan,China,455001[20]The first people''s hospital of Changzhou,Changzhou,Jiangsu,China,213004[21]Shanghai Chest Hospital,Shanghai,Shanghai,China,200030
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.