Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,154
- 试验地点
- 1
- 主要终点
- Progression Free Survival (Part B)
研究概览
简要总结
The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone 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. Additional information on the health-related quality of life (HRQOL) will be collected.
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
- 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
BIBW 2992 and Paclitaxel
Patients will be treated with BIBW 2992daily with a medium dose and weekly administration of Paclitaxel at a dose of 80 mg/m2
干预措施: BIBW 2992 (Drug)
Investigator's choice of chemotherapy
Patients will be treated with investigator's choice of chemotherapy
干预措施: Investigator´s choice of chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (Part B)
时间窗: From randomization until disease progression or death; Up to 32 months
Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy. Median was calculated from the Kaplan-Meier curve.
次要结局
- Progression Free Survival (Part A)(From first dose administration until disease progression or death; Up to 51 months)
- Overall Survival (Part B)(From randomization until death; Up to 32 months)
- Objective Response (Part A)(Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months)
- Objective Response (Part B)(Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months)
- Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.(From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B))