NCT00363415已完成3 期
A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
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
- 908
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
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
- •Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
- •Capable of self-care but may be unable to carry out any work activities.
- •No prior anticancer therapy for SCLC
排除标准
- •have previously participated in a study involving pemetrexed
- •have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
研究组 & 干预措施
A
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: carboplatin (Drug)
B
Active Comparator
干预措施: etoposide (Drug)
B
Active Comparator
干预措施: carboplatin (Drug)
结局指标
主要结局
Overall Survival
时间窗: baseline to date of death from any cause (up to 19.6 months)
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
次要结局
- Overall Survival (Subgroups)(baseline to date of death from any cause (up to 19.6 months))
- Progression Free Survival(baseline to measured progressive disease (up to 14.7 months))
- Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)(baseline and 6 cycles (21-day cycles))
- Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)(baseline to date of death due to any cause (up to 19.6 months))
研究者
研究点 (1)
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