An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) 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
- 481
- 试验地点
- 118
- 主要终点
- Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
研究概览
简要总结
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-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 treated-patients
Patients diagnosed with EGFR mutation positive non-small cell lung cancer (NSCLC) locally advanced or metastatic who have never been treated with EGFR tyrosine kinase inhibitors (TKI) received a daily dose of 40 milligrams (mg) of afatinib (Giotrif®), in the form of film-coated tablet over a 28 day cycle. Afatinib was taken orally with 250 milliliters (mL) of water at the same time of the day and without eating anything for at least 3 hours. Patients continued on treatment for as long as there was no disease progression or no other trial withdrawal criteria. The dose was reduced to 30 mg or 20 mg once daily when the initial dose was not tolerated by the patient.
干预措施: Afatinib (Drug)
结局指标
主要结局
Number of Patients With Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
时间窗: From first drug administration to last drug administration plus 28 days of residual effect period. Up to 3866 days.
Number of patients with any treatment emergent adverse event (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
次要结局
未报告次要终点