JPRN-jRCT2080225266已完成3 期
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of sotorasib Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen K.K.
- 入组人数
- 345
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 100age old（—）
- 性别
- All
入选标准
- •1. Men or women greater than or equal to 18 years old.
- •2. ECOG <= 1
- •3. 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
- •1. Active brain metastases
- •2. Myocardial infarction within 6 months of study day 1
- •3. Gastrointestinal (GI) tract disease causing the inability to take oral medication
研究者
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