NCT00850577终止2 期
A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology
Bristol-Myers Squibb22 个研究点 分布在 3 个国家目标入组 255 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 255
- 试验地点
- 22
- 主要终点
- Progression free survival based on tumor assessments (CT scans/MRI)
研究概览
简要总结
The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ECOG Performance Status (PS) <=1
- •Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
- •Measurable disease by RECIST guidelines
排除标准
- •Evidence of predominantly squamous-cell histology
- •Known CNS metastases
- •Any prior antineoplastic systemic regimens for NSCLC
- •Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident
- •Gross hemoptysis (≥1/2 tsp of red blood)
- •Uncontrolled hypertension
- •Clinically significant cardiovascular disease
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
研究组 & 干预措施
Paclitaxel/Carboplatin/CT-322
Active Comparator
干预措施: Paclitaxel (Drug)
Paclitaxel/Carboplatin/CT-322
Active Comparator
干预措施: Carboplatin (Drug)
Paclitaxel/Carboplatin/CT-322
Active Comparator
干预措施: CT-322 (Drug)
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Active Comparator
干预措施: Paclitaxel (Drug)
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Active Comparator
干预措施: Carboplatin (Drug)
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Active Comparator
干预措施: Bevacizumab (Drug)
Paclitaxel/Carboplatin/Bevacizumab/Placebo
Active Comparator
干预措施: Bevacizumab placebo (ie saline solution) (Drug)
结局指标
主要结局
Progression free survival based on tumor assessments (CT scans/MRI)
时间窗: every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
次要结局
- Overall survival (OS) between 2 arms(every 12 weeks)
- Objective tumor response rate (ORR) between 2 arms(every 6 weeks)
- Safety in the CT-322 plus carboplatin and paclitaxel arm(weekly)
研究者
研究点 (22)
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2 期
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