NCT03215706已完成3 期
A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Bristol-Myers Squibb116 个研究点 分布在 8 个国家目标入组 719 人开始时间: 2017年8月24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
- 719
- 试验地点
- 116
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
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
- •Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- •Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
- •Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period
排除标准
- •Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
- •Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
- •Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment
- •Other protocol inclusion/exclusion criteria may apply
研究组 & 干预措施
Module B
Active Comparator
Chemotherapy Combination
干预措施: Paclitaxel (Drug)
Module B
Active Comparator
Chemotherapy Combination
干预措施: Pemetrexed (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Ipilimumab (Biological)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Nivolumab (Biological)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Carboplatin (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Paclitaxel (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Pemetrexed (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
干预措施: Cisplatin (Drug)
Module B
Active Comparator
Chemotherapy Combination
干预措施: Carboplatin (Drug)
Module B
Active Comparator
Chemotherapy Combination
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
次要结局
- Progression Free Survival (PFS) by BICR(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Objective Response Rate (ORR) by BICR(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Duration of Response (DoR)(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Time to Response (TTR)(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- PFS by BICR by PD-L1 Tumor Cell Expression(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- OS by PD-L1 Tumor Cell Expression(From date of randomization to date of death (assessed up to October 2024, approximately 72 months))
- PFS by BICR by Tumor Mutational Burden(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- ORR by BICR by Tumor Mutational Burden(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- OS by Tumor Mutational Burden(From date of randomization to date of death (assessed up to October 2024, approximately 72 months))
研究者
研究点 (116)
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