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临床试验/NCT02477826
NCT02477826已完成3 期

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb290 个研究点 分布在 5 个国家目标入组 2,747 人开始时间: 2015年8月5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
2,747
试验地点
290
主要终点
Progression-Free Survival Per BICR

研究概览

简要总结

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced 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

入选标准

  • Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
  • 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

排除标准

  • Subjects with untreated Central nervous system (CNS) metastases are excluded
  • Subjects with an active, known or suspected autoimmune disease are excluded
  • Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
  • Other protocol defined inclusion/exclusion criteria apply

研究组 & 干预措施

Arm A: Nivolumab

Experimental

Nivolumab intravenously (IV) as specified

干预措施: Nivolumab (Drug)

Arm B: Nivolumab + Ipilimumab

Experimental

Nivolumab + Ipilimumab IV as specified

干预措施: Nivolumab (Drug)

Arm B: Nivolumab + Ipilimumab

Experimental

Nivolumab + Ipilimumab IV as specified

干预措施: Ipilimumab (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Nivolumab (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Carboplatin (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Cisplatin (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Gemcitabine (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Pemetrexed (Drug)

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

干预措施: Paclitaxel (Drug)

Arm D: Platinum doublet chemotherapy

Experimental

Chemotherapy administered on specified days of IV chemotherapy

干预措施: Carboplatin (Drug)

Arm D: Platinum doublet chemotherapy

Experimental

Chemotherapy administered on specified days of IV chemotherapy

干预措施: Cisplatin (Drug)

Arm D: Platinum doublet chemotherapy

Experimental

Chemotherapy administered on specified days of IV chemotherapy

干预措施: Gemcitabine (Drug)

Arm D: Platinum doublet chemotherapy

Experimental

Chemotherapy administered on specified days of IV chemotherapy

干预措施: Pemetrexed (Drug)

Arm D: Platinum doublet chemotherapy

Experimental

Chemotherapy administered on specified days of IV chemotherapy

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Progression-Free Survival Per BICR

时间窗: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)

Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Overall Survival

时间窗: From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)

OS for all randomized participants is the time between randomization date and the date of death from any cause.

次要结局

  • Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale(Week 12)
  • Objective Response Rate (ORR) Per BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks))

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (290)

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