Status:
ACTIVE_NOT_RECRUITING
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
Eligibility Criteria
Inclusion
- Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
- No brain metastasis
- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
- Ability to provide surgical or biopsy tumor tissue for biomarkers
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion
- Participants with an active, known or suspected autoimmune disease
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2027
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT04025879
Start Date
November 5 2019
End Date
July 30 2027
Last Update
October 16 2025
Active Locations (108)
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1
Local Institution - 0104
Tampa, Florida, United States, 33612
2
Local Institution - 0040
Atlanta, Georgia, United States, 30342
3
Local Institution - 0120
Augusta, Georgia, United States, 30912
4
Local Institution - 0145
Chicago, Illinois, United States, 60611