NCT02481830已完成3 期
An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)
Bristol-Myers Squibb151 个研究点 分布在 8 个国家目标入组 569 人开始时间: 2015年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 569
- 试验地点
- 151
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
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
- •Histologically or cytologically confirmed small cell lung cancer (SCLC)
- •Subjects with either limited or extensive disease stage at the initial diagnosis
- •Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Untreated or symptomatic central nervous system (CNS) metastases
- •Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
- •Inadequate hematologic or hepatic function
研究组 & 干预措施
Arm A Nivolumab
Experimental
Nivolumab intravenous infusion as specified
干预措施: Nivolumab (Drug)
Arm B Chemotherapy Topotecan
Active Comparator
Topotecan as specified
干预措施: Topotecan (Drug)
Arm B Chemotherapy Amrubicin
Active Comparator
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
干预措施: Amrubicin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
次要结局
- Progression Free Survival (PFS)(From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months))
- Objective Response Rate (ORR)(From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months))
研究者
研究点 (151)
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