An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 582
- 试验地点
- 87
- 主要终点
- Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
研究概览
简要总结
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
详细描述
CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057
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
- •Men & women ≥18 years of age
- •Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease
- •Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
- •Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient
排除标准
- •Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent)
- •Subjects with carcinomatous meningitis
- •Subjects with active or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
- •Prior therapy with anti-programmed death-1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- •Prior treatment with Docetaxel
- •Treatment with any investigational agent within 14 days of first administration of study treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: Nivolumab
Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: Nivolumab (Biological)
Arm B: Docetaxel
Docetaxel 75 mg/m^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
时间窗: Randomization until 413 deaths, up to March 2015 (approximately 29 months)
Overall survival was defined as the time from randomization to the date of death. A participant who has not died will be censored at last known date alive. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Median and hazard ratio computed using Kaplan-Meier method.
次要结局
- Percentage of Participants Experiencing Disease-Related Symptom Improvement by Week 12(Randomization to Week 12)
- Objective Response Rate (ORR)(From randomization to date of objectively documented progression (up to approximately 110 months))
- Overall Survival (OS) by PD-L1 Expression at Baseline(From randomization to the date of death or last known date alive (up to approximately 110 months))
- Time To Objective Response (TTOR)(From randomization to the date of first confirmed response (up to approximately 110 months))
- Duration of Objective Response (DOOR)(From randomization to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months))
- Progression-Free Survival (PFS)(From randomization to first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 110 months))
- Objective Response Rate (ORR) by PD-L1 Expression at Baseline(From randomization to date of objectively documented progression (up to approximately 110 months))