An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• A signed written informed consent is required before performing any study-related operations
• Age greater than or equal to 18 years old
• Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
• No history of systemic anticancer therapy to the local advanced/metastatic disease
• Expected survival period greater than or equal to 3 months
• Having at least one target lesion according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) ≤ 1
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Chest Hospital ,Capital Medical University
RECRUITING
Beijing
Beijing Tiantan Hospital, Captal Medical University
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy Of Medical Sciences
RECRUITING
Beijing
Pecking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Cangzhou hospital of integrated TCM-WM Hebei
RECRUITING
Cangzhou
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Sichuan province cancer hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian cancer Hospital
NOT_YET_RECRUITING
Fuzhou
The first Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital-Mammary gland of internal
NOT_YET_RECRUITING
Haerbin
The First affiliated hospital Zhejiang university school of medicine
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang School of Medicine
NOT_YET_RECRUITING
Hangzhou
Anhui Province cancer hospital
NOT_YET_RECRUITING
Hefei
Jilin cancer hospital
NOT_YET_RECRUITING
Jilin
Shandong Cancer Hospital
RECRUITING
Jinan
LinYi Cancer Hospital
NOT_YET_RECRUITING
Linyi
Jiangsu province hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer hospital & Guangxi Cancer Institute
NOT_YET_RECRUITING
Nanning
The affiliated hospital of Qingdao university
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
The First Hospital Of China Medical University
NOT_YET_RECRUITING
Shenyang
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
NOT_YET_RECRUITING
Shenzhen
Shanxi province cancer hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Hospital Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Tianjin Medical University Cancer Institute Hospital
NOT_YET_RECRUITING
Tianjin
Hubei cancer hospital
NOT_YET_RECRUITING
Wuhan
Tongji Hospital Tongji Medical College of Hust
NOT_YET_RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuxi People's Hospital
NOT_YET_RECRUITING
Wuxi
The First Affiliated Hospital of Xi'An Jiaotong University
NOT_YET_RECRUITING
Xi’an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hosipital Of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Shanghai Allist Pharmaceuticals Co., Ltd
zhenhua.gong@allist.com.cn
021-80423288
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 392
Treatments
Experimental: JAB-21822+JAB-3312
JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle
Active_comparator: Tislelizumab combined with Pemetrexed + Carboplatin
Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle
Related Therapeutic Areas
Sponsors
Leads: Allist Pharmaceuticals, Inc.