NCT01377376终止3 期
A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 主要终点
- Overall survival
研究概览
简要总结
The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARQ 197
Experimental
ARQ 197 and Erlotinib
干预措施: ARQ 197 and Erlotinib (Drug)
Placebo
Placebo Comparator
Placebo and Erlotinib
干预措施: Placebo and Erlotinib (Drug)
结局指标
主要结局
Overall survival
次要结局
- Progression free survival
- Number of patients with adverse events
- Objective response rate
研究者
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Unknown
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