Status:
RECRUITING
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Resectable Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug...
Eligibility Criteria
Inclusion
- Key
- Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
- For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
- All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
- A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, hepatic and kidney function as defined in the protocol
- Key
Exclusion
- Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
- Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
- Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- Patients with a history of myocarditis
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2029
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06161441
Start Date
July 16 2024
End Date
November 28 2029
Last Update
November 21 2025
Active Locations (133)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Clermont Oncology Center
Clermont, Florida, United States, 34711
3
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
4
University of Illinois
Chicago, Illinois, United States, 60612