A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 30
- 主要终点
- PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
研究概览
简要总结
To compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated subjects with KRAS p.G12C mutated non-small cell lung cancer (NSCLC)
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Men or women greater than or equal to 18 years old.
- •Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment
排除标准
- •Active brain metastases
- •Myocardial infarction within 6 months of study day 1
- •Gastrointestinal (GI) tract disease causing the inability to take oral medication
研究组 & 干预措施
Dexamethasone 2mg Tablets
干预措施: Dexamethasone 2mg Tablets (Drug)
SOTORASIB
干预措施: SOTORASIB (Drug)
DOCETAXEL
干预措施: DOCETAXEL (Drug)
结局指标
主要结局
PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
PFS - defined as time from randomization until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
次要结局
- Overall survival - defined as time from randomization until death from any cause.
- Objective response (complete response [CR] + partial response [PR]), assessed per RECIST v1.1. Response will be assessed by BICR. Complete response and PR require confirmatory repeat radiologic assessment at no less than 4 weeks after the original response. The normal subsequent assessment is acceptable to confirm response.
- Change from baseline (cycle 1 day 1) over time to week 12 in disease related symptoms of: - Dyspnea as measured by a 4-item dyspnea domain from QLQ-C30 and QLQ-LC13 - Cough as measured by QLQ-LC13 - Chest Pain as measured by QLQ-LC13
- Change from baseline over time to week 12 in: - Physical functioning as measured by QLQ-C30 - Global health status as measured by QLQ-C30
研究者
Medical Information
Scientific
Amgen Inc.