2023-503714-77-00招募中2 期
A Phase 2 Trial of Combination Therapies with Adagrasib in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 35
- 主要终点
- Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
研究概览
简要总结
Evaluate the efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for advanced NSCLC patients with KRAS G12C mutation.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 2 Trial of Combination Therapies with Adagrasib in Advanced NSCLC with KRAS G12C Mutation
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation. a. Cohort A* (closed): squamous or nonsquamous histology b. Cohorts C and E*: nonsquamous histology only
排除标准
- •Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy (CIT in Cohorts A and E only), any therapy targeting KRAS G12C mutation (eg, sotorasib) , or received maintenance therapy, eg, pembrolizumab and/or pemetrexed following completion 4-6 cycles of a platinum-based regimen administered in the first-line setting (Cohort C only)
- •Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment.
- •Active brain metastases.
结局指标
主要结局
Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Cohort C: PFS at 6 months (PFS6)
Cohort C: PFS at 6 months (PFS6)
次要结局
- Cohorts C and E: Dose-limiting toxicities (DLTs) during safety lead-in (SLI)
- Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events (AEs) and laboratory abnormalities
- Summary statistics of adagrasib concentrations
- Secondary efficacy endpoints: Duration of response (DOR)
研究者
Mirati Study Locator
Scientific
Mirati Therapeutics Inc.
研究点 (35)
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