Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation
赞助:
Asan Medical Center
合作者:
信息的提供 (责任方):
Sang-We Kim，Asan Medical Center
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 30, 2018 | ||
| 预计主要完成日期 | June 30, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Objective response rate[ Time Frame: At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months] ] ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Capmatinib in Patients With Non-small Cell Lung Cancer Harboring cMET exon14 Skipping Mutation | ||
| 正式标题 ICMJE | An Open-label, Multicenter, Phase II Study of Capmatinib in Patients With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation | ||
| 简要概况 | This study is a phase II, single-arm, open label study under an umbrella trial for NSCLC. This clinical study is targeted for the patients who harbor exon 14 skipping mutation of MET and all patients will be treated with Capmatinib. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
27 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2022 | ||
| 预计主要完成日期 | June 30, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Subjects with histologically or cytologically confirmed, unresectable stage IIIB/IV NSCLC that carries MET exon 14 skipping alteration by molecular testing, as per NGS and RT PCR. - ECOG performance status of 0 to 2 - Male or female; ≥ 18 - Subjects with measurable lesion (using RECIST 1.1 criteria) - Subjects must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since - Patients who have progressed during or after 1st line or 2nd line therapy prior to the first dose of capmatinib. For patient who have received prior platinum containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease, those treatments are regarded as 1st line if the progression has occurred < 12 months from last therapy. Exclusion Criteria: - Any major operation or irradiation within 4 weeks of baseline disease assessment - Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug - Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms - Patients who have received more than 2 lines of prior systemic therapy, which include chemo, immune and targeted therapy | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Korea, Republic of | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Sang-We Kim，Asan Medical Center | ||
| 研究赞助商 ICMJE | Asan Medical Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Asan Medical Center | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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