A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Progression Free Survival During Maintenance Phase
研究概览
简要总结
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A: Pemetrexed + Best Supportive Care
Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
干预措施: pemetrexed (Drug)
A: Pemetrexed + Best Supportive Care
Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
干预措施: Best Supportive Care (Drug)
B: Best Supportive Care
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
干预措施: Best Supportive Care (Drug)
结局指标
主要结局
Progression Free Survival During Maintenance Phase
时间窗: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
次要结局
- Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])(First dose of study drug during IP to PD or date of death from any cause up to 33.6 months)
- Overall Survival During Maintenance Phase(Randomization to PD or date of death from any cause up to 31.3 months)
- Overall Survival During Overall Period (IP + MP)(First dose of study drug during IP to PD or date of death from any cause up to 34.1 months)
- Number of Participants With Adverse Events (AEs) During Overall Period(First dose of study drug during IP through overall study completion (up to 34.3) months)
- Tumor Response Rate and Disease Control Rate After Induction Phase (IP)(Randomization to measured PD up to 31.4 months)