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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 392
- 试验地点
- 64
- 主要终点
- Outcome Progression-free Survival (PFS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
JAB-21822+JAB-3312
JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle
干预措施: JAB-3312 (Drug)
JAB-21822+JAB-3312
JAB-21822 tablet, 21 days as a treatment cycle; JAB-3312 tablet/capsule, 21 days as a treatment cycle
干预措施: JAB-21822 (Drug)
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
干预措施: Tislelizumab (Drug)
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
干预措施: Pemetrexed (Drug)
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
干预措施: Carboplatin (Drug)
结局指标
主要结局
Outcome Progression-free Survival (PFS)
时间窗: 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).
次要结局
- Half life (t1/2)(Pre-dose Day 1 up to Day 64)
- Time to Maximum Plasma Concentration (Tmax)(Pre-dose Day 1 up to Day 64)
- Number of Participants With Treatment-Emergent Adverse Events(From Baseline up to 4 years)
- Objective Response Rate (ORR)(From Baseline up to 4 years)
- Overall Survival (OS)(From Baseline up to 4 years)
- Number of Participants With Clinically Significant Changes in Vital Signs(From Baseline up to 4 years)