NCT01003899已完成2 期
A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Best Objective Response
研究概览
简要总结
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（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 (BIBW 2992)
Experimental
patient to receive afatinib(BIBW 2992) po QD in an open-label manner
干预措施: afatinib (BIBW 2992) (Drug)
结局指标
主要结局
Percentage of Participants With Best Objective Response
时间窗: Baseline till progression or death
Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).
次要结局
- Percentage of Participants With Disease Control (DC)(Baseline till progression or death)
- Time to OR(Baseline till progression or death)
- Progression Free Survival (PFS) Time(Baseline till end of study or death)
- Duration of Disease Control (DC)(Baseline till progression or death)
- Duration of OR(Baseline till progression or death)
研究者
研究点 (3)
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