Phase 3
N=2,747
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02477826 ↗Enrolled (actual)
2,747
Serious AEs
59.8%
Results posted
Oct 2025
Primary outcome: Primary: Progression-Free Survival Per BICR — 5.06; 4.17; 5.55; 4.90 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Drug); Ipilimumab (Drug); Carboplatin (Drug); Cisplatin (Drug); Gemcitabine (Drug); Pemetrexed (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival Per BICR |
5.06; 4.17; 5.55; 4.90; 5.55; 4.70 | — |
| PRIMARY Overall Survival |
17.12; 15.70; 14.88; 17.45; 15.21; 12.19 | — |
| SECONDARY Objective Response Rate (ORR) Per BICR |
36.4; 27.5; 29.7; 26.2; 37.9; 23.1 | — |
| SECONDARY Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale |
31.3; 35.4; 25.7; 33.2; 28.8; 37.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02477826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.