NCT00457392已完成3 期
A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.
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
- Triple (Participant, 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
- •Patients with locally advanced/metastatic non-small cell lung cancer
- •Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
排除标准
- •Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
- •History of or known brain metastases
研究组 & 干预措施
1
Experimental
干预措施: erlotinib (Drug)
1
Experimental
干预措施: sunitinib (Drug)
2
Active Comparator
干预措施: erlotinib (Drug)
2
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline to death or 28 days after last dose for the last participant
Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.
次要结局
- Duration of Response (DR)(Baseline to disease progression or death or discontinuation from study or 28 days after last dose)
- EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score(Baseline and End of Treatment (EOT) or Withdrawal)
- One-year Survival Probability(Baseline until death or until 28 days after last dose for the last participant)
- Progression-Free Survival (PFS)(Baseline to disease progression or death due to any cause or 28 days after last dose)
- Percentage of Participants With Objective Response (OR)(Baseline to disease progression or discontinuation from study or 28 days after last dose)
研究者
研究点 (1)
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