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)
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
Checked against the public recordLast updated Mar 2, 2023 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.