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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
JAB-21822 administered orally as a tablet
Tislelizumab administered as an intravenous (IV) infusion
JAB-3312 administered orally as a tablet or capsule
Pemetrexed administered as an intravenous (IV) infusion
Carboplatin administered as an intravenous (IV) infusion
Anhui Province cancer hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPecking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China
Outcome Progression-free Survival (PFS)
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).
Time frame: From Baseline up to 4 years
Objective Response Rate (ORR)
Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1
Time frame: From Baseline up to 4 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause
Time frame: From Baseline up to 4 years
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline up to 4 years
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From Baseline up to 4 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Pre-dose Day 1 up to Day 64
Half life (t1/2)
Time frame: Pre-dose Day 1 up to Day 64
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chest Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFujian cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China
NOT_YET_RECRUITING...and 27 more locations