Phase 3
Completed 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)
Source: ClinicalTrials.gov NCT02477826 ↗Enrolled (actual)
2,747
Serious AEs
59.8%
Results posted
Oct 2025
Primary outcomePrimary: Progression-Free Survival Per BICR — 5.06; 4.17; 5.55; 4.90 months
◆ Published Evidence
Highly cited
2,837citations · ~405 / year
Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
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.
Linked Publications (5)
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Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer.
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Five-Year Survival Outcomes With Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment for Metastatic Non-Small-Cell Lung Cancer in CheckMate 227.
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First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1.
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Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis.
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A community challenge to predict clinical outcomes after immune checkpoint blockade in non-small cell lung cancer.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.