Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,314
- 试验地点
- 208
- 主要终点
- Progression Free Survival (PFS) as Assessed by Central Independent Review
研究概览
简要总结
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.
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
BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
干预措施: BIBF 1120 plus docetaxel (Drug)
Placebo plus docetaxel
Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
干预措施: placebo plus docetaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as Assessed by Central Independent Review
时间窗: From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)
Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.
次要结局
- Duration of Confirmed Objective Tumour Response(From randomisation until cut-off date 15 February 2013)
- Time to Confirmed Objective Tumour Response(From randomisation until cut-off date 15 February 2013)
- Disease Control(From randomisation until cut-off date 15 February 2013)
- Quality of Life (QoL)(From randomisation until cut-off date 15 February 2013)
- Duration of Disease Control(From randomisation until cut-off date 15 February 2013)
- Clinical Improvement(From randomisation until cut-off date 15 February 2013)
- Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide(Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3)
- Overall Survival (Key Secondary Endpoint)(From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients ))
- Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review(From randomisation until cut-off date 15 February 2013)
- Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator(From randomisation until cut-off date 15 February 2013)
- Objective Tumour Response(From randomisation until cut-off date 15 February 2013)
- Change From Baseline in Tumour Size(From randomisation until cut-off date 15 February 2013)
- Incidence and Intensity of Adverse Events(From the first drug administration until 28 days after the last drug administration, up to 42 months)