Phase 3
Completed N=541
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Stage IV or Recurrent Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02041533 ↗
Enrolled (actual)
541
Serious AEs
73.7%
Results posted
Jul 2017
Primary outcomePrimary: Progression-Free Survival in Participants With PD-L1 Expression >= 5% — 4.21; 5.88 Months — p=0.2511
◆ Published Evidence
Highly cited
2,574citations · ~286 / year
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
Summary
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
Linked Publications (2)
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First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
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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 in Participants With PD-L1 Expression >= 5% |
4.21; 5.88 | 0.2511 |
| SECONDARY Progression-Free Survival in All Randomized Participants |
4.21; 5.82 | — |
| SECONDARY Overall Survival in Participants With PD-L1 Expression >= 5% |
14.36; 13.21 | — |
| SECONDARY Overall Survival in All Randomized Participants |
13.73; 13.80 | — |
| SECONDARY Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5% |
26.1; 33.5 | — |
| SECONDARY Disease-related Symptom Improvement Rate by Week 12 |
35.4; 33.7 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1
- Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
- PD-L1+ on immunohistochemistry testing performed by central lab
- Men and women, ages ≥ 18 years of age
Exclusion Criteria
- Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy
- Known anaplastic lymphoma kinase (ALK) translocations
- Untreated central nervous system (CNS) metastases
- Previous malignancies
- Active, known or suspected autoimmune disease
Data sourced from ClinicalTrials.gov (NCT02041533) 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.