JPRN-jRCT2080225053终止2 期
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1>= 50%
ovartis Pharma. K.K.0 个研究点目标入组 96 人开始时间: 2020年2月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 96
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 ot applicable（—）
- 性别
- All
入选标准
- •Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
- •Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
- •Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS >= 50%)
- •ECOG performance status score =< 1
- •Have at least 1 measurable lesion by RECIST 1.1
- •Have adequate organ function
排除标准
- •Prior treatment with a MET inhibitor or HGF-targeting therapy
- •Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- •Have untreated symptomatic central nervous system (CNS) metastases
- •Clinically significant, uncontrolled heart diseases
- •Prior palliative radiotherapy for bone lesions =< 2 weeks prior to starting study treatment
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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