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

NCT06161441 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 2

Started

2024-07-16

Last updated

2026-08-10

Condition(s) studied

Resectable Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Fianlimab →Cemiplimab →Pemetrexed →Paclitaxel →Carboplatin →Cisplatin →Placebo

Fianlimab: Administered intravenously (IV) every 3 weeks (Q3W)

Cemiplimab: Administered IV Q3W

Pemetrexed: Administered IV Q3W

Paclitaxel: Administered IV Q3W

Carboplatin: Administered IV Q3W

Cisplatin: Administered IV Q3W

Placebo: Administered IV Q3W

Study 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" 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples — Up to 24 months

Trial sites (123)

Facility	City	Region
Clermont Oncology Center	Clermont	Florida
University of Illinois	Chicago	Illinois
University of Kansas Cancer Center-Westwood	Westwood	Kansas
Henry Ford Health System	Detroit	Michigan
Mercy South	St Louis	Missouri
University of Rochester	Rochester	New York
Kaiser Permanente Northwest	Portland	Oregon
Virginia Cancer Care Specialist, PC	Fairfax	Virginia
Eastern Health	Box Hill	Victoria
St Vincent's Hospital	Fitzroy	Victoria
St John of God Murdoch Hospital	Murdoch	Western Australia
Orlandi Oncologia	Providencia	Metropolitan Region
Clinica Santa Maria	Santiago	Providencia
Centro de Oncologia de Precision	Las Condes	Region Metropolitana, Santiago
Oncocentro APYS	Viña del Mar	Valparaiso
Centre de Oncologie de Gentilly	Nancy	Grand Est
Institut de Cancerologie de l'Ouest	Saint-Herblain	Nantes
Centre Hospitalier Universitaire (CHU) Bordeaux	Bordeaux	New Aquitaine
CHU Limoges	Limoges	New Aquitaine
APHP - Hopital Ambroise Pare	Boulogne-Billancourt	France
CHU Dijon	Dijon	France
Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec	Nantes	France
Uneos - Hopital R Schuman	Vantoux	France
Chi Creteil	Créteil	Île-de-France Region
Hopital Cochin	Paris	Île-de-France Region
Cancer Center of Adjara	Batumi	Georgia
Israeli Georgian Medical Research Clinic Helsicore	Tbilisi	Georgia
Llc Todua Clinic	Tbilisi	Georgia
LTD New Hospitals	Tbilisi	Georgia
High Technology Medical Center, University Clinic Tbilisi	Tbilisi	Georgia
Institute of Clinical Oncology	Tbilisi	Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery	Tbilisi	Georgia
TIM - Tbilisi Institute of Medicine	Tbilisi	Georgia
Multiprofile Clinic Consilium Medulla	Tbilisi	Georgia
LKI LUngenfachklinik Immenhausen	Immenhausen	Hesse
Evang. Kliniken Essen-Mitte	Essen	North Rhine-Westphalia
LungenClinic	Großhansdorf	Schleswig-Holstein
Klinikum Esslingen	Esslingen am Neckar	Germany
Universitatsklinium Giesse	Giessen	Germany
Asklepios Klinikum Harburg	Hamburg	Germany

+ 83 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06161441 on ClinicalTrials.gov ↗ ← All trials in the USA