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.

Status: Recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntary participation in the study and sign of written informed consent after full informed consent, willing and able to comply with the study procedures and requirements specified in the protocol;

• Age greater than or equal to 18 years old; male and female; eastern cooperative oncology group performance status (ECOG) score 0-1; expected survival period greater than or equal to 3 months;

• Pathologically confirmed locally advanced, unresectable and / or metastatic non-small cell lung cancer (stage III b / III c / IV of american joint committee on cancer (AJCC) 8th);

• Subjects must provide adequate and qualified tumor tissue specimens (surgical resection samples or puncture / biopsy tissue samples within 2 years prior to screening) for confirmation of the KRAS G12C mutation in the central laboratory;

• Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy;

• Having at least one target lesion according to RECIST 1.1;

• Good function of the major organs;

• Female subjects of childbearing age should agree that contraception must be used during the study and within 6 months after the end of the study; the serum pregnancy test is negative within 7 days before study enrollment and must be non-lactating subjects; male subjects should agree that contraception must be used during the study and within 6 months after the end of the study period.

Locations
Other Locations
China
Anyang Tumor Hospital
NOT_YET_RECRUITING
Anyang
Affiliated Hospital of Hebei University
NOT_YET_RECRUITING
Baoding
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Beijing Chest Hospital,Capital Medical University
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
The Fifth medical center of Chinese PLA General Hospital
NOT_YET_RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital Of Central South University
NOT_YET_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Changzhi People's Hospital
NOT_YET_RECRUITING
Changzhi
The first people's hospital of Changzhou
NOT_YET_RECRUITING
Changzhou
The Affiliated Hospital of Chengde Medical College
NOT_YET_RECRUITING
Chengde
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Army Medical Center
NOT_YET_RECRUITING
Chongqing
Chongqing Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Chongqing University Three Gorges Hospital
NOT_YET_RECRUITING
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The Southwest hospital of AMU
NOT_YET_RECRUITING
Chongqing
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
The First Affiliated Hospital Of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guilin Medical College
NOT_YET_RECRUITING
Guilin
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
Hainan Provincial People's Hospital
NOT_YET_RECRUITING
Haikou
The First Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Anhui Province Hospital
NOT_YET_RECRUITING
Hefei
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
NOT_YET_RECRUITING
Jiamusi
Shandong Cancer Hospitai
NOT_YET_RECRUITING
Jinan
Jining First People's Hospital
NOT_YET_RECRUITING
Jining
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING
Lanzhou
Lanzhou University Second Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of Science and Technology
NOT_YET_RECRUITING
Luoyang
The Affiliated Hospital Of Southwest Medical Unerversity
NOT_YET_RECRUITING
Luzhou
Mianyang Central Hospital
NOT_YET_RECRUITING
Mianyang
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
Jiangxi Provincial People's Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
General Hospital of eastern theater command
NOT_YET_RECRUITING
Nanjing
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Nantong Tumor Hospital
NOT_YET_RECRUITING
Nantong
Nanyang second general hospital
NOT_YET_RECRUITING
Nanyang
The First affiliated Hospital of Nanyang Medical College
NOT_YET_RECRUITING
Nanyang
The second people's hospital of neijiang
NOT_YET_RECRUITING
Neijiang
Qingdao Municipal Hospital
NOT_YET_RECRUITING
Qingdao
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai Chest Hospital
RECRUITING
Shanghai
Shengjing hospital of China medical university
NOT_YET_RECRUITING
Shenyang
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Tai’an
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tangshan People's Hospital
NOT_YET_RECRUITING
Tangshan
Tianjin medical University cancer
NOT_YET_RECRUITING
Tianjin
The Affiliated Tumor Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Weifang people's Hospital
NOT_YET_RECRUITING
Weifang
Weihai Municipal Hospital
NOT_YET_RECRUITING
Weihai
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
Zhongnan hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Jiangyin People's Hospital
NOT_YET_RECRUITING
Wuxi
Wuxi People's Hospital
NOT_YET_RECRUITING
Wuxi
The First Affiliated Hospital of Xi'An JiaoTong University
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
The Second Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING
Xian
The First Affiliated Hospital Of Xinxiang Medical Unerversity
NOT_YET_RECRUITING
Xinxiang
Xuchang Central Hospital
NOT_YET_RECRUITING
Xuchang
The Affiliated Hospital Of XuZhou Medical University
NOT_YET_RECRUITING
Xuzhou
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Yulin First People's Hospital
NOT_YET_RECRUITING
Yulin
The Affiliated Hospital of Guangdong Medical University
NOT_YET_RECRUITING
Zhanjiang
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Henan Provincial People's Hospita
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Zhengzhou
The Second Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Shun Lu, Doctor
shun_lu@hotmail.com
13601813062
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 522
Treatments
Experimental: D-1553 Tablet
D-1553 Tablet,21 days as a treatment cycle.
Active_comparator: Docetaxel Injection
Docetaxel Injection,21 days as a treatment cycle.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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