A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 97
- 主要终点
- Objective Response Rate (ORR) as Assessed Per RECIST v1.1
研究概览
简要总结
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
详细描述
This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subject must be ≥18 years of age.
- •Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)
排除标准
- •Primary central nervous system (CNS) tumors
- •Known or suspected leptomeningeal or brain metastases or spinal cord compression
- •Clinically significant cardiac disease
- •Known impairment of GI function that would alter the absorption
- •Active autoimmune disease requiring systemic treatment within past 2 years
- •History of severe allergic reactions to any of the study intervention components
- •Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
- •Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor
研究组 & 干预措施
RMC-4630 and sotorasib, Safety Run-in
Safety Run-In:
RMC-4630 and sotorasib
干预措施: RMC-4630 (Drug)
RMC-4630 and sotorasib, Safety Run-in
Safety Run-In:
RMC-4630 and sotorasib
干预措施: Sotorasib (Drug)
RMC-4630 and sotorasib, Expansion
Dose Expansion:
RMC-4630 and sotorasib
干预措施: RMC-4630 (Drug)
RMC-4630 and sotorasib, Expansion
Dose Expansion:
RMC-4630 and sotorasib
干预措施: Sotorasib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) as Assessed Per RECIST v1.1
时间窗: 31 months
Evaluation of the antitumor effects of RMC-4630 and sotorasib in locally advanced or metastatic NSCLC patients with KRASG12C mutation with and without co-existing genetic aberrations in specific genes such as STK11/LKB1, KEAP1, and PIK3CA after failure of prior standard therapy. Objective Response Rate (%) is defined as the proportion of patients with Best Overall Response of confirmed CR, or PR. Response was confirmed by a repeat assessment no less than 28 days.
次要结局
- Progression-free Survival (PFS) as Assessed Per RECIST v1.1(31 months)
- Overall Survival (OS)(31 months)
- Incidence, Nature and Severity of TEAEs, SAEs(31 months)
- Clinically Significant Changes in Vital Signs(31 months)
- Clinically Significant Changes in Laboratory Tests(31 months)
- Trough and Approximate Peak Concentrations of RMC-4630(31 months)
- Disease Control Rate (DCR) as Assessed Per RECIST v.1.1(31 months)
- Clinically Significant Changes in ECGs(31 months)
- Trough and Approximate Peak Concentrations of Sotorasib(31 months)
- Duration of Response (DOR) as Assessed Per RECIST v1.1(31 months)