Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 participa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2024
Estimated Enrollment :
925 Patients enrolled
Trial Details
Trial ID
NCT04026412
Start Date
October 8 2019
End Date
November 26 2024
Last Update
July 24 2025
Active Locations (183)
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1
Local Institution - 0119
La Jolla, California, United States, 92093
2
Local Institution - 0207
San Francisco, California, United States, 94115
3
Local Institution - 0166
San Francisco, California, United States, 94143
4
Local Institution - 0129
Lone Tree, Colorado, United States, 80124