A Randomized, Open-Label, Phase 2 Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Subjects With Recurrent/Stage IV Non-Squamous, Non-Small Cell Lung Cancer Who Have Not Progressed After Four Cycles of a Platinum-Based First Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 13
- 主要终点
- Overall Survival of Participants During the Study - All Treated Participants
研究概览
简要总结
The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.
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
- •For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
- •Inclusion Criteria:
- •Non-Squamous, Non-Small Cell Lung Cancer
- •Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Not progressing after 4 cycles of a platinum-based first line chemotherapy
排除标准
- •Brain Metastases (unless stable)
- •Autoimmune Diseases
研究组 & 干预措施
Arm 2: Pemetrexed
干预措施: Pemetrexed (Biological)
Arm 1: Ipilimumab
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Overall Survival of Participants During the Study - All Treated Participants
时间窗: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started
Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.
次要结局
- Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants(Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.)
- Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants(Day 1 to Date of last patient, last visit, approximately 7 months after study started.)