NCT02961270Unknown2 期
Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation
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
- •Patients with stage IIIB/IV non-small cell lung cancer
- •Patients with uncommon epidermal growth factor receptor (EGFR) mutation
- •Targeted-therapy-naive patients
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Evaluable target lesions according to RECIST 1.1 for tumour response assessment
排除标准
- •Wild-type EGFR
- •Positive 19 del and/or 21 L858R mutation
- •Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
- •Patients who have documented history of interstitial lung disease
研究组 & 干预措施
icotinib
Experimental
patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
干预措施: Icotinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 10 months
次要结局
- tumor response rate(2 months)
- overall survival(24 months)
研究者
Shengyu Zhou
Director
Chinese Academy of Medical Sciences
研究点 (1)
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