LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 36
- 主要终点
- Progression-free Survival
研究概览
简要总结
To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation
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
Arm A BIBW 2992
Patients receive a tablet of BIBW 2992 daily until progression or unacceptable toxicity
干预措施: BIBW 2992 (Drug)
Arm B Chemotherapy
Patients receive Gemcitabine and Cisplatin, maximum is 6 courses
干预措施: Gemcitabine+Cisplatin (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168
The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS. Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates.
次要结局
- Duration of Disease Control(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Overall Survival (OS)(From randomisation up to 374 weeks)
- Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing(Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.)
- Pharmacokinetics of Afatinib at Day 43(Day 43 (course 3, visit 1))
- Time to Objective Response (OR)(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Change From Baseline in Body Weight(Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.)
- Health Related Quality of Life (HRQOL): Time of Deterioration in Pain(Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.)
- Changes in Safety Laboratory Parameters(From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.)
- Objective Response (OR)(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Disease Control (DC)(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Duration of Objective Response(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Pharmacokinetics of Afatinib at Day 22(Day 22 (course 2, visit 1))
- Pharmacokinetics of Afatinib at Day 29(Day 29 (course 2, visit 2))
- Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea(Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.)
- Tumour Shrinkage(Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374)
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.)
- Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events(From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.)