Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
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
- •Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
- •At least one prior chemotherapy for palliative therapy
- •Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
排除标准
- •Concurrent administration of any other tumor therapy
- •Pregnant or breast feeding
- •Serious concomitant disorders
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Pemetrexed
干预措施: pemetrexed (Drug)
Docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
Overall Survival
时间窗: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)
Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
次要结局
- Progression-Free Survival (PFS)(baseline to measured progressive disease (up to 24 months after study enrollment))
- Pharmacology Toxicity(first dose of study drug up to 24 months)
- Overall Tumor Response(baseline to measured tumor response (up to 24 months after study enrollment))
- Duration of Response(time of response to progressive disease (up to 24 months))