NCT01953913已完成3 期
An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 33
- 主要终点
- Percentage of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor). Secondary objective is to assess the time to symptomatic progression (as judged by investigator).
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
Experimental
Patient will receive afatinib once daily
干预措施: Afatinib (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: From first drug administration up to 28 days after last drug administration, up to 1624 days.
Percentage of participants with serious adverse events (SAEs).
次要结局
- Time to Symptomatic Progression (TTSP)(From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.)
- Percentage of Participants With Drug-related (Afatinib-related) Adverse Events(From first drug administration up to 28 days after last drug administration, up to 1624 days.)
研究者
研究点 (33)
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