JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation
- Conditions
- Advanced Non-squamous Non-small-cell Lung CancerMetastatic Non-squamous Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06416410
- Lead Sponsor
- Allist Pharmaceuticals, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 392
- 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
- Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
- Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
- Subjects with untreated central nervous system (CNS) metastases were excluded;
- Uncontrolled pleural effusion, pericardial effusion, and ascites
- Subjects with impaired heart function or clinically significant heart disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JAB-21822+JAB-3312 JAB-3312 JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle JAB-21822+JAB-3312 JAB-21822 JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle Tislelizumab combined with Pemetrexed + Carboplatin Tislelizumab Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle Tislelizumab combined with Pemetrexed + Carboplatin 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 Tislelizumab combined with Pemetrexed + Carboplatin Pemetrexed Tislelizumab injection, 21 days as a treatment cycle; Pemetrexed injection, 21 days as a treatment cycle; Carboplatin injection, 21 days as a treatment cycle
- Primary Outcome Measures
Name Time Method Outcome Progression-free Survival (PFS) From Baseline up to 4 years 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).
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events From Baseline up to 4 years Time to Maximum Plasma Concentration (Tmax) Pre-dose Day 1 up to Day 64 Half life (t1/2) Pre-dose Day 1 up to Day 64 Objective Response Rate (ORR) From Baseline up to 4 years Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1
Overall Survival (OS) From Baseline up to 4 years OS is defined as the time from randomization until death due to any cause
Number of Participants With Clinically Significant Changes in Vital Signs From Baseline up to 4 years
Trial Locations
- Locations (37)
Anhui Province cancer hospital
🇨🇳Hefei, Anhui, China
Pecking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy Of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Captal 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
Fujian cancer Hospital
🇨🇳Fuzhou, Fujian, China
The first Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
🇨🇳Shenzhen, Guangdong, China
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