NCT00806923已完成3 期
A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,044
- 主要终点
- Progression-free survival
研究概览
简要总结
This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.
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
- None
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
- •adult patients, >=18 years of age;
- •documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
- •adequate liver and kidney function;
- •women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.
排除标准
- •prior chemotherapy or treatment with another systemic cancer therapy;
- •surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
- •brain metastasis or spinal cord compression;
- •fertile men, and women of childbearing potential, not using adequate contraception;
- •treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
研究组 & 干预措施
1
Experimental
干预措施: Cisplatin (Drug)
1
Experimental
干预措施: Gemcitabine (Drug)
1
Experimental
干预措施: bevacizumab [Avastin] (Drug)
2
Experimental
干预措施: Cisplatin (Drug)
2
Experimental
干预措施: Gemcitabine (Drug)
2
Experimental
干预措施: bevacizumab [Avastin] (Drug)
3
Placebo Comparator
干预措施: Cisplatin (Drug)
3
Placebo Comparator
干预措施: Gemcitabine (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Event driven
次要结局
- Safety:AEs, laboratory tests, SAEs, coagulation parameters(Throughout study)
- Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.(Event driven)
研究者
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