CTRI/2007/091/000039未知2 期
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in PreviouslyUntreated Subjects With Lung Cancer
The pharmaceutical company sponsoring this study is Bristol-MyersSquibb5 个研究点 分布在 1 个国家目标入组 0 人开始时间: 待定
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 5
- 主要终点
- Primary Outcome Measures:EORTC-QLQ-30 questionnaire [ Time Frame: completed at everyvisit ]
研究概览
简要总结
The trial is part of a global trial. In India it is proposed to recruit 22 patients from Indian sites. Globally trial has started recruitment. In India it is expected to begin on 11 April 20008.
研究设计
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
入选标准
- •Documented NSCLC or SCLCECOG of 0 or 1.
排除标准
- •�� Brain metastases�� Autoimmune disease�� Known HIV, Hep B or Hep C infection�� Peripheral neuropathy ≥ grade 2.
结局指标
主要结局
Primary Outcome Measures:EORTC-QLQ-30 questionnaire [ Time Frame: completed at everyvisit ]
时间窗: [ Time Frame: completed at everyvisit ]
次要结局
- Safety evaluations in all study arms(At defined timepoints per the protocol)
研究者
研究点 (5)
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