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)

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Gemcitabine

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 2, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?141 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Southern Cancer Center, Inc.Mobile, Alabama
Banner MD Anderson Cancer CenterGilbert, Arizona
Local Institution - 0034Tucson, Arizona
Local Institution - 0016Stanford, California
University Of Colorado HospAurora, Colorado
Local Institution - 0020New Haven, Connecticut
Local Institution - 0030Miami, Florida
Local Institution - 0033Ocala, Florida
H. Lee Moffitt Cancer CenterTampa, Florida
Local Institution - 0010Atlanta, Georgia
Northwest Georgia Oncology Center, P.C.Marietta, Georgia
Local Institution - 0037Chicago, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 2, 2023. Always confirm current availability with the study team.

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