NCT01932229Unknown2 期
An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced NSCLC
- •EGFR mutation or six months or longer benefit from EGFR TKIs
- •Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
- •Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
排除标准
- •Inability to take oral drugs
研究组 & 干预措施
Afatinib treatment
Experimental
干预措施: Afatinib treatment (Drug)
结局指标
主要结局
Progression free survival
时间窗: One year
次要结局
- Overall survival(One year)
研究者
研究点 (1)
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