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)
Completed · Phase 3
Conditions studied: Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02477826
- Run by
- Bristol-Myers Squibb
- People needed
- 2747
- Starts
- 2015-08-05
- Expected to finish
- 2024-10-25
- Last updated by the study team
- 2025-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Local Institution - 0017 — San Francisco, California, United States
- Local Institution - 0021 — New Haven, Connecticut, United States
- Local Institution - 0001 — Atlanta, Georgia, United States
- Local Institution - 0013 — Marietta, Georgia, United States
- Local Institution - 0004 — Lexington, Kentucky, United States
- Local Institution - 0115 — St Louis, Missouri, United States
- Local Institution - 0005 — Buffalo, New York, United States
- Local Institution - 0019 — New York, New York, United States
- Local Institution - 0014 — Cleveland, Ohio, United States
- Local Institution - 0009 — Columbus, Ohio, United States
- Local Institution - 0007 — Allentown, Pennsylvania, United States
- Local Institution - 0075 — Langhorne, Pennsylvania, United States
- Local Institution - 0299 — Philadelphia, Pennsylvania, United States
- Local Institution - 0012 — Philadelphia, Pennsylvania, United States
- Local Institution - 0015 — Sayre, Pennsylvania, United States
- Local Institution - 0008 — Charleston, South Carolina, United States
- Local Institution - 0080 — Greenville, South Carolina, United States
- Local Institution - 0010 — Greenville, South Carolina, United States
- Local Institution - 0020 — Nashville, Tennessee, United States
- Local Institution - 0306 — Dallas, Texas, United States
- Local Institution - 0003 — Dallas, Texas, United States
- Local Institution - 0102 — Houston, Texas, United States
- Local Institution - 0011 — Salt Lake City, Utah, United States
- Local Institution - 0074 — Kennewick, Washington, United States
- Southern Cancer Center, Inc. — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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