Active Not RecruitingPhase 2NCT06161441

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

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" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life

Checked against the public recordLast updated Aug 10, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 2
U.S. locations123
SponsorRegeneron Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: Fianlimab; Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: 1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8 2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol 3. 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 4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate bone marrow, hepatic and kidney function as defined in the protocol Key Exclusion Criteria: 1. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol 2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol 4. 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. 5. Patients with a history of myocarditis Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Clermont Oncology CenterClermont, Florida
  • University of IllinoisChicago, Illinois
  • University of Kansas Cancer Center-WestwoodWestwood, Kansas
  • Henry Ford Health SystemDetroit, Michigan
  • Mercy SouthSt Louis, Missouri
  • University of RochesterRochester, New York
  • Kaiser Permanente NorthwestPortland, Oregon
  • Virginia Cancer Care Specialist, PCFairfax, Virginia
  • Eastern HealthBox Hill, Victoria
  • St Vincent's HospitalFitzroy, Victoria
  • St John of God Murdoch HospitalMurdoch, Western Australia
  • Orlandi OncologiaProvidencia, Metropolitan Region

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2026. Always confirm current availability with the study team.

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