Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 585
- 试验地点
- 90
- 主要终点
- Overall Survival
研究概览
简要总结
This randomized, double-blind, multi-center Phase IIb/III trial will be performed in patients with NSCLC who have received previous treatment with at least one but not more than two lines of cytotoxic chemotherapy (one line must have been a platinum-containing regimen) and either gefitinib or erlotinib for a period of at least 12 weeks and then progressed.
The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.
Patients enrolled into the trial will be treated and followed until death or lost to follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
Placebo
Patients receive placebo once daily
干预措施: placebo (Drug)
BIBW 2992
Patients receive BIBW 2992 tablets once daily
干预措施: BIBW 2992 (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization until death or the last patient out date, an average of 12 months
Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock. For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010. For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013.
次要结局
- Progression-free Survival (PFS)(From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months)
- Objective Response Rate (OR)(From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months)