2023-506783-14-00招募中3 期
J2G-MC-JZJC: LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 48
- 主要终点
- PFS per REIST 1.1 by BICR
研究概览
简要总结
To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) therapy, pemetrexed, and pembrolizumab in patients with advanced or metastatic RET fusion-positive NSCLC
To compare PFS of selpercatinib with the combination of platinum-based (carboplatin or cisplatin) and pemetrexed therapy, with or without pembrolizumab, in patients with advanced or metastatic RET fusion-positive NSCLC
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must have advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation therapy
- •Participants must have a RET gene fusion and sufficient tumor tissue available for confirmatory testing
- •Participants must be in fair to good health and not Have another serious medical condition
- •Participants must not have had prior chemotherapy for metastatic lung cancer. chemotherapy in the adjuvant/neoadjuvant setting is permitted
- •Participants must not have disease that has spread to the brain and is causing symptoms
- •Participants must be able to swallow capsules
- •Participants must be willing to use highly effective contraception during the study
排除标准
- •Participants must not have a heart condition that puts you at risk for abnormal heart rhythms.
结局指标
主要结局
PFS per REIST 1.1 by BICR
PFS per REIST 1.1 by BICR
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (48)
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