An Open Label Trial of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Safety Assesment
研究概览
简要总结
The main aim of this study is to evaluate the safety and tolerability of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine Kinase Inhibitor (TKI)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Afatinib
patient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability
干预措施: Afatinib (Drug)
结局指标
主要结局
Safety Assesment
时间窗: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
Safety was assessed by: 1. All serious adverse events (SAEs) 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib 3. Non-serious AEs assessed by the treating physician as related to afatinib.
次要结局
未报告次要终点