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)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 2747
- Locations
- 290
- Primary Endpoint
- Progression-Free Survival Per BICR
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Arm A: Nivolumab
Nivolumab intravenously (IV) as specified
Intervention: Nivolumab
Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
Intervention: Nivolumab
Arm B: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab IV as specified
Intervention: Ipilimumab
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Nivolumab
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Carboplatin
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Cisplatin
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Gemcitabine
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Pemetrexed
Arm C: Nivolumab + Platinum doublet chemotherapy
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Intervention: Paclitaxel
Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Intervention: Carboplatin
Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Intervention: Cisplatin
Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Intervention: Gemcitabine
Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Intervention: Pemetrexed
Arm D: Platinum doublet chemotherapy
Chemotherapy administered on specified days of IV chemotherapy
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Progression-Free Survival Per BICR
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))