NCT03513666已完成2 期
Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment：a Multi-center, Single Arm Phase II Study
Shanghai Junshi Bioscience Co., Ltd.5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment：a multi-center, single arm phase II study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only the patients meeting all the following criteria can be eligible to participate in the trial:
- •Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time:
- •Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease;
- •No exon 20 T790M mutation after failure of EGFR-TKI therapy;
- •At least one measurable lesion (in accordance with RECIST 1.1);
排除标准
- •Patients who fulfill any of the following criteria must be excluded from the study:
- •Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%;
- •Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.;
- •Previous systemic chemotherapy for advanced NSCLC;
- •EGFR-TKI therapy within two weeks prior to enrollment;
结局指标
主要结局
Objective response rate (ORR)
时间窗: 12 weeks
The primary endpoint is the antitumor activities in this study
次要结局
- DOR(18 months)
- PFS(18 months)
- OS(18 months)
研究者
研究点 (5)
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