A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 939
- 试验地点
- 1
- 主要终点
- Investigator-assessed Objective Progression-free Survival (PFS)
研究概览
简要总结
This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo.
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
- Quadruple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pemetrexed + cisplatin followed by pemetrexed
pemetrexed plus cisplatin followed by pemetrexed plus best supportive care
干预措施: Pemetrexed (Drug)
pemetrexed + cisplatin followed by pemetrexed
pemetrexed plus cisplatin followed by pemetrexed plus best supportive care
干预措施: Cisplatin (Drug)
pemetrexed + cisplatin followed by pemetrexed
pemetrexed plus cisplatin followed by pemetrexed plus best supportive care
干预措施: Best Supportive Care (Other)
pemetrexed + cisplatin followed by placebo
pemetrexed plus cisplatin followed by placebo plus best supportive care
干预措施: Pemetrexed (Drug)
pemetrexed + cisplatin followed by placebo
pemetrexed plus cisplatin followed by placebo plus best supportive care
干预措施: Cisplatin (Drug)
pemetrexed + cisplatin followed by placebo
pemetrexed plus cisplatin followed by placebo plus best supportive care
干预措施: Placebo (Drug)
pemetrexed + cisplatin followed by placebo
pemetrexed plus cisplatin followed by placebo plus best supportive care
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Investigator-assessed Objective Progression-free Survival (PFS)
时间窗: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)
Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
次要结局
- Independently-assessed Objective Progression-free Survival (PFS)(Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months))
- Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase(Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months))
- Percentage of Participants With Serious Adverse Events During Maintenance Phase(Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months))
- Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off(Baseline to date of measured progressive disease (up to 19.3 months))
- Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)(Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months))
- Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)(Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months))
- Overall Survival (OS)(Date of randomization to the date of death from any cause up to 39.5 months)
- Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score(Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months))
- Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off(Date of randomization to date of measured PD (up to 19.3 months))