A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

Completed · Phase 3

Conditions studied: Non-Small Cell Lung Cancer (NSCLC)

In brief

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Key facts

Study ID

NCT04026412

Run by

Bristol-Myers Squibb

People needed

925

Starts

2019-10-08

Expected to finish

2024-11-26

Last updated by the study team

2025-07-24

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
• Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

You may not qualify if…

• Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
• Active infection requiring systemic therapy within 14 days prior to randomization
• History of organ or tissue transplant that requires systemic use of immune suppressive agents
• Prior thoracic radiotherapy
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0207 — San Francisco, California, United States
• Local Institution - 0166 — San Francisco, California, United States
• Local Institution - 0129 — Lone Tree, Colorado, United States
• Local Institution - 0233 — Jacksonville, Florida, United States
• Local Institution - 0219 — Orlando, Florida, United States
• Local Institution - 0039 — Pensacola, Florida, United States
• Local Institution - 0125 — Atlanta, Georgia, United States
• Local Institution - 0165 — Augusta, Georgia, United States
• Local Institution - 0218 — Edgewood, Kentucky, United States
• Local Institution - 0108 — Bethesda, Maryland, United States
• Local Institution - 0116 — Traverse City, Michigan, United States
• Local Institution - 0053 — Cincinnati, Ohio, United States
• Local Institution - 0131 — Cincinnati, Ohio, United States
• Local Institution - 0188 — Cincinnati, Ohio, United States
• Local Institution - 0112 — Cleveland, Ohio, United States
• Local Institution - 0124 — Cleveland, Ohio, United States
• Local Institution - 0047 — Cleveland, Ohio, United States
• Local Institution - 0123 — Youngstown, Ohio, United States
• Local Institution - 0077 — Charleston, South Carolina, United States
• Local Institution - 0191 — Austin, Texas, United States
• Local Institution - 0079 — Bryan, Texas, United States
• Local Institution - 0130 — Dallas, Texas, United States
• Local Institution - 0071 — Burlington, Vermont, United States
• Local Institution - 0044 — CABA, Buenos Aires, Argentina
• Local Institution - 0119 — La Jolla, California, United States

Full record on ClinicalTrials.gov

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