A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Completed · Phase 3
Conditions studied: Non Small Cell Lung Cancer
In brief
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.
Key facts
- Study ID
- NCT02998528
- Run by
- Bristol-Myers Squibb
- People needed
- 505
- Starts
- 2017-03-04
- Expected to finish
- 2024-12-06
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
- Lung function capacity capable of tolerating the proposed lung surgery
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Available tissue of primary lung tumor
You may not qualify if…
- Presence of locally advanced, inoperable or metastatic disease
- Participants with active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
- Other protocol defined inclusion/exclusion criteria apply
Where it is running
- Local Institution - 0081 — Los Angeles, California, United States
- Local Institution - 0025 — Denver, Colorado, United States
- Local Institution - 0007 — Plainville, Connecticut, United States
- Local Institution - 0173 — Hollywood, Florida, United States
- Local Institution - 0136 — Miami, Florida, United States
- Local Institution - 0054 — Orlando, Florida, United States
- Orlando Health, Inc. — Orlando, Florida, United States
- Indian River Medical Center — Vero Beach, Florida, United States
- Northwest Georgia Oncology Center, P.C. — Marietta, Georgia, United States
- Local Institution - 0015 — Chicago, Illinois, United States
- Local Institution - 0002 — Chicago, Illinois, United States
- Illinois Cancer Specialists — Niles, Illinois, United States
- Local Institution - 0171 — Fort Wayne, Indiana, United States
- Local Institution - 0170 — Lexington, Kentucky, United States
- Local Institution - 0186 — Louisville, Kentucky, United States
- University Medical Center New Orleans — New Orleans, Louisiana, United States
- Local Institution - 0151 — Baltimore, Maryland, United States
- Local Institution - 0001 — Baltimore, Maryland, United States
- Local Institution - 0008 — Boston, Massachusetts, United States
- Southcoast Center For Cancer — Fairhaven, Massachusetts, United States
- Local Institution - 0006 — Newton, Massachusetts, United States
- Local Institution - 0012 — Detroit, Michigan, United States
- Local Institution - 0090 — Hattiesburg, Mississippi, United States
- St Vincent Frontier Cancer Center — Billings, Montana, United States
- Local Institution - 0121 — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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