Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 13
- 主要终点
- Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
研究概览
简要总结
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.
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
Docetaxel and placebo
patients to receive backbone chemotherapy and placebo
干预措施: docetaxel (Drug)
Docetaxel and placebo
patients to receive backbone chemotherapy and placebo
干预措施: placebo (Drug)
Docetaxel and Nintedanib
patients to receive backbone chemotherapy and nintedanib
干预措施: docetaxel (Drug)
Docetaxel and Nintedanib
patients to receive backbone chemotherapy and nintedanib
干预措施: nintedanib (Drug)
结局指标
主要结局
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
时间窗: Up to 6 months.
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
次要结局
未报告次要终点