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)

Completed · Phase 3

Conditions studied: Stage IV or Recurrent Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT02041533

Run by

Bristol-Myers Squibb

People needed

541

Starts

2014-03-27

Expected to finish

2022-05-27

Last updated by the study team

2023-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Local Institution - 0034 — Tucson, Arizona, United States
• Local Institution - 0016 — Stanford, California, United States
• University Of Colorado Hosp — Aurora, Colorado, United States
• Local Institution - 0020 — New Haven, Connecticut, United States
• Local Institution - 0030 — Miami, Florida, United States
• Local Institution - 0033 — Ocala, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Local Institution - 0010 — Atlanta, Georgia, United States
• Northwest Georgia Oncology Center, P.C. — Marietta, Georgia, United States
• Local Institution - 0037 — Chicago, Illinois, United States
• Local Institution - 0014 — Lexington, Kentucky, United States
• Crescent City Research Consortium, LLC — Marrero, Louisiana, United States
• Local Institution - 0024 — Baltimore, Maryland, United States
• Local Institution - 0036 — Boston, Massachusetts, United States
• Local Institution - 0070 — Boston, Massachusetts, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Local Institution - 0009 — New York, New York, United States
• Local Institution - 0005 — New York, New York, United States
• University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• Local Institution - 0003 — Durham, North Carolina, United States
• Local Institution - 0012 — Cleveland, Ohio, United States
• Local Institution - 0027 — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Southern Cancer Center, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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