A Randomised, 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
- 345
- 试验地点
- 132
- 主要终点
- Progression-Free Survival (PFS) Time
研究概览
简要总结
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.
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
BIBW 2992 tablet once daily until progression
干预措施: BIBW 2992 (Drug)
Cisplatin/Pemetrexed
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
干预措施: Pemetrexed (Drug)
Cisplatin/Pemetrexed
Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) Time
时间窗: Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression
PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
次要结局
- Percentage of Patients With Objective Response (OR)(Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
- Percentage of Participants With Disease Control (DC)(Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
- Overall Survival (OS) Time(From randomisation to cut-off date (17MAR2017).)
- Tumour Shrinkage(Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
- Change From Baseline in Body Weight(Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Throughout the trial until progression (every 3 weeks), up to 28 months.)
- Trough Plasma Concentrations of Afatinib at Day 22(Day 22.)
- Trough Plasma Concentrations of Afatinib at Day 43(Day 43.)
- Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing(Throughout the trial until progression (every 3 weeks).)
- HRQOL: Time to Deterioration in Dyspnoea(Throughout the trial until progression (every 3 weeks).)
- Trough Plasma Concentrations of Afatinib at Day 29(Day 29.)
- HRQOL: Time to Deterioration in Pain(Throughout the trial until progression (every 3 weeks).)