NCT00087711已完成3 期
A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-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
- 1,713
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.
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
- •Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
- •No prior chemotherapy for lung cancer.
- •Patients must have at least one uni-dimensionally measurable lesion.
- •Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.
排除标准
- •Treatment with any drug within the last 30 days that has not received regulatory approval.
- •Serious cardiac condition.
- •Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
- •Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- •Presence of fluid retention that cannot be controlled by drainage.
研究组 & 干预措施
B
Active Comparator
干预措施: cisplatin (Drug)
A
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: cisplatin (Drug)
B
Active Comparator
干预措施: gemcitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: baseline to date of death from any cause
次要结局
- Duration of response(time of response to progressive disease)
- Time to treatment failure(baseline to stopping treatment)
- Time to progressive disease(baseline to measured progressive disease)
- Progression free survival(baseline to measured progressive disease)
研究者
研究点 (1)
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