CTIS2022-501863-41-00招募中1 期
A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non small Cell Lung Cancers, Negative for PD L1, and Positive for KRAS p.G12C (CodeBreaK 202) - 20190341
Amgen Inc.0 个研究点目标入组 723 人开始时间: 2023年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 723
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Men or women greater than or equal to 18 years old, Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing, No history of systemic anticancer therapy in metastatic/non-curable settings, ECOG = 1
排除标准
- •Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology, Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, Symptomatic (treated or untreated) brain metastases, Gastrointestinal (GI) tract disease causing the inability to take oral medication, Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina, Prior therapy with a KRAS G12C inhibitor
研究者
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