An Open-label, Multicenter, Phase II Study of Capmatinib in Patients With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Capmatinib
Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)
干预措施: Capmatinib (Drug)
结局指标
主要结局
Objective response rate
时间窗: 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
次要结局
- Progression-free survival(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)
- Duration of response(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)
- Overall survival(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)
研究者
Sang-We Kim
Professor
Asan Medical Center