A multinational, randomized, double-blind study comparing aflibercept versusplacebo in patients treated with second-line docetaxel after failure of one platinumbased therapy for locally advanced or metastatic non-small-cell lung cancer(NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC).
研究概览
简要总结
Trial will be conducted in 24 countries all over the world The Indian target - 40 patients Indian status - No patients randomized till date Planned date of first enrolment - 10th Apr 2008 India randomised 23 patients in the study. Randomisation ended on 5th February 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •?Histological/cytological proven locally advanced or metastatic non-small cell lung cancer ?Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease ?Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 ?Adequate renal, liver and bone marrow functions.
排除标准
- •?Squamous histology/cytology ?Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization ?Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to > 25% of bone marrow ?Prior docetaxel treatment ?Uncontrolled hypertension.
结局指标
主要结局
To demonstrate overall survival (OS) improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC).
时间窗: Clinical examination will be performed every 3 weeks before each treatment cycle during the treatment period and then overall survival will be evaluated by collecting status information at 2 month intervals until death or the study cut-off date, whichever comes first
次要结局
- Progression Free Survival (PFS)(PFS is defined as time interval between the date of randomization and the time of occurrence of the first documented among the following events:)