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Brief Title: 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
Official Title: A Randomized, Controlled, Double-blind, Double-simulated, Multicenter Phase III Clinical Study Evaluating 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.
Study ID: NCT06300177
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anhui Province Hospital, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Xuanwu Hospital Capital Medical University, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University, Beijing, Beijing, China
The Fifth medical center of Chinese PLA General Hospital, Beijing, Beijing, China
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
The Southwest hospital of AMU, Chongqing, Chongqing, China
Army Medical Center, Chongqing, Chongqing, China
Chongqing University Three Gorges Hospital, Chongqing, Chongqing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital Of Fujian Medical University, Fuzhou, Fujian, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital, Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College, Guilin, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Yulin First People's Hospital, Yulin, Guangxi, China
Guizhou Provincial People's Hospital, Guiyang, Guizhou, China
The Second Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
Hainan Provincial People's Hospital, Haikou, Hainan, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
The Affiliated Hospital of Chengde Medical College, Chengde, Hebei, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Tangshan People's Hospital, Tangshan, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital), Jiamusi, Heilongjiang, China
Anyang Tumor Hospital, Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Nanyang second general hospital, Nanyang, Henan, China
The First affiliated Hospital of Nanyang Medical College, Nanyang, Henan, China
The First Affiliated Hospital Of Xinxiang Medical Unerversity, Xinxiang, Henan, China
Xuchang Central Hospital, Xuchang, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital Zhejiang University School of Medicine, Zhengzhou, Henan, China
Henan Provincial People's Hospita, Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
Zhongnan hospital of Wuhan University, Wuhan, Hubei, China
The Second Xiangya Hospital Of Central South University, Changsha, Hunan, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The first people's hospital of Changzhou, Changzhou, Jiangsu, China
General Hospital of eastern theater command, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
Wuxi People's Hospital, Wuxi, Jiangsu, China
Jiangyin People's Hospital, Wuxi, Jiangsu, China
The Affiliated Hospital Of XuZhou Medical University, Xuzhou, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, China
The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Shengjing hospital of China medical university, Shenyang, Liaoning, China
Shandong Cancer Hospitai, Jinan, Shandong, China
Jining First People's Hospital, Jining, Shandong, China
Qingdao Municipal Hospital, Qingdao, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong, China
Weifang people's Hospital, Weifang, Shandong, China
Weihai Municipal Hospital, Weihai, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, Shanghai, Shanghai, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Changzhi People's Hospital, Changzhi, Shanxi, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'An JiaoTong University, Xi'an, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University, Xian, Shanxi, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
The Affiliated Hospital Of Southwest Medical Unerversity, Luzhou, Sichuan, China
Mianyang Central Hospital, Mianyang, Sichuan, China
The second people's hospital of neijiang, Neijiang, Sichuan, China
Tianjin medical University cancer, Tianjin, Tianjin, China
The Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China