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 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: R3767-ONC-22662023-505172-29-00
• Study Type: interventional
• Target: 195
• Locations: 12 countries
• Sites: 123

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" 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

Conditions

Resectable Non-small Cell Lung Cancer

Keywords

Stage II to IIIB (N2); NSCLC; Neoadjuvant therapy; Subsequent adjuvant therapy; PeriOperative

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples

  Up to 24 months

Secondary Outcomes (44)

• Event-Free Survival (EFS)

  Up to 3 years

• Major pathological response (MPR) by BIPR in post-treatment resected tumor samples

  Up to 24 months

• MPR by local pathology review in post-treatment resected tumor samples

  Up to 24 months

• Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

  Up to 24 months

• Occurrence of Adverse events (AEs)

  Up to 5 years

Study Arms (3)

Arm A

EXPERIMENTAL

Randomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab

Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo

Arm B

EXPERIMENTAL

Randomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab

Drug: Fianlimab; Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

Arm C

EXPERIMENTAL

Randomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab

Drug: Fianlimab; Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

Interventions

Fianlimab DRUG

Administered intravenously (IV) every 3 weeks (Q3W)

Also known as: REGN3767

Arm B; Arm C

Cemiplimab DRUG

Administered IV Q3W

Also known as: REGN2810, Libtayo

Arm A; Arm B; Arm C

Pemetrexed DRUG

Administered IV Q3W

Also known as: Alimta

Arm A; Arm B; Arm C

Paclitaxel DRUG

Administered IV Q3W

Also known as: Taxol

Arm A; Arm B; Arm C

Carboplatin DRUG

Administered IV Q3W

Also known as: Paraplatin

Arm A; Arm B; Arm C

Cisplatin DRUG

Administered IV Q3W

Also known as: Platinol

Arm A; Arm B; Arm C

Placebo DRUG

Administered IV Q3W

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (123)

Clermont Oncology Center

Clermont, Florida, 34711, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Kansas Cancer Center-Westwood

Westwood, Kansas, 66205, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mercy South

St Louis, Missouri, 63128, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Virginia Cancer Care Specialist, PC

Fairfax, Virginia, 22031, United States

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

St John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

Orlandi Oncologia

Providencia, Metropolitan Region, 7500713, Chile

Location

Clinica Santa Maria

Santiago, Providencia, 7520378, Chile

Location

Centro de Oncologia de Precision

Las Condes, Region Metropolitana, Santiago, 7560908, Chile

Location

Oncocentro APYS

Viña del Mar, Valparaiso, 2520598, Chile

Location

Centre de Oncologie de Gentilly

Nancy, Grand Est, 54000, France

Location

Institut de Cancerologie de l'Ouest

Saint-Herblain, Nantes, 44805, France

Location

Centre Hospitalier Universitaire (CHU) Bordeaux

Bordeaux, New Aquitaine, 33076, France

Location

CHU Limoges

Limoges, New Aquitaine, 87042, France

Location

APHP - Hopital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

CHU Dijon

Dijon, 21000, France

Location

Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec

Nantes, 44093, France

Location

Uneos - Hopital R Schuman

Vantoux, 57070, France

Location

Chi Creteil

Créteil, Île-de-France Region, 94010, France

Location

Hopital Cochin

Paris, Île-de-France Region, 75014, France

Location

Cancer Center of Adjara

Batumi, 6000, Georgia

Location

Israeli Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Llc Todua Clinic

Tbilisi, 0112, Georgia

Location

LTD New Hospitals

Tbilisi, 0114, Georgia

Location

High Technology Medical Center, University Clinic Tbilisi

Tbilisi, 0144, Georgia

Location

Institute of Clinical Oncology

Tbilisi, 0159, Georgia

Location

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, 0159, Georgia

Location

TIM - Tbilisi Institute of Medicine

Tbilisi, 0160, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

LKI LUngenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

Location

Evang. Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

LungenClinic

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location

Universitatsklinium Giesse

Giessen, 35392, Germany

Location

Asklepios Klinikum Harburg

Hamburg, 21075, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH

Neuss, 41462, Germany

Location

Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale

Naples, Campania, 80131, Italy

Location

UOC Oncoematologia AOU Vanvitelli

Naples, Campania, 80131, Italy

Location

Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara)

Ferrara, Emilia-Romagna, 44124, Italy

Location

AUSL Piacenza

Piacenza, Emilia-Romagna, 29121, Italy

Location

Careggi University Hospital

Florence, Firenze, 50134, Italy

Location

UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest

Livorno, Livorno, 57124, Italy

Location

ASST Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Location

Azienda Sanitaria Territoriale di Pesaro e Urbino

Pesaro, Pesaro And Urbino, 61121, Italy

Location

Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

Aviano, Pordenone, 33081, Italy

Location

FPO- IRCCS, Istituto di Candiolo

Candiolo, Turin, 10060, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, 56124, Italy

Location

Istituto Tumori Giovanni Paolo II (Istituto di Ricovero e Cura a Carattere Scientifico Bari)

Bari, 70124, Italy

Location

ASST Cremona

Cremona, 26100, Italy

Location

Niguarda Cancer Center

Milan, 20162, Italy

Location

Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

Novara, 28100, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena

Rome, 00144, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia

Udine, 33100, Italy

Location

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, Negeri / Wilayah Persekutuan, 50603, Malaysia

Location

Hospital Pulau Pinang

George Town, Pulau Pinang, 10990, Malaysia

Location

Hospital Umum Sarawak

Kuching, 93586, Malaysia

Location

National Cancer Center

Gyeonggi-do, Gyeonggi-do, 10408, South Korea

Location

The Catholic University of Korea St Vincents Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-Gu, 21565, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 8308, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Clinico Universitario Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital General Universitario Elche

Elche, Alicante, 3203, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, 18015, Spain

Location

Son Espases

Palma, Balearic Islands, 07120, Spain

Location

IOB Institute of Oncology Quiron

Barcelona, Catalonia, 08023, Spain

Location

Instituto Oncologico Dr Rosell

Barcelona, Catalonia, 08028, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Alvaro Cunqueiro Hospital

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu

Barcelona, 8243, Spain

Location

Catalan Institute of Oncology

Girona, 17007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28020, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital De Valme

Seville, 41001, Spain

Location

Fundacion IVO

Valencia, 46009, Spain

Location

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, 46026, Spain

Location

Changhua Christian Hospital

Changhua, Changhua County, 50006, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin, 807, Taiwan

Location

Hualien Tzu Chi Hospital

Hualien City, 97002, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110301, Taiwan

Location

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, 116, Taiwan

Location

Acibadem Adana Hastanesi

Adana, Adana, 1330, Turkey (Türkiye)

Location

Ege University Faculty of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Kocaeli University Hospital

Kocaeli, Marmara, 41380, Turkey (Türkiye)

Location

Faculty of Medicine of Sakarya University

Sakarya, Marmara, 54290, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, 42080, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Kurupelit, Samsun, 55139, Turkey (Türkiye)

Location

Medical Point Gaziantep Hastanesi

Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)

Location

Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Baskent University Adana Turgut Noyan Hospital

Adana, Yuregir, 01230, Turkey (Türkiye)

Location

Adana City Education and Research Hospital

Adana, Yuregir, 1060, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Liv Hospital Ankara

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Cancer Institute

Ankara, 06230, Turkey (Türkiye)

Location

Memorial Ankara Hospital

Ankara, 0906520, Turkey (Türkiye)

Location

Ankara University Faculty of Medicine

Ankara, 6620, Turkey (Türkiye)

Location

Koc University

Istanbul, 34010, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital

Istanbul, 34870, Turkey (Türkiye)

Location

MeSH Terms

Interventions

cemiplimab; Pemetrexed; Paclitaxel; Carboplatin; Cisplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: July 16, 2024
• Primary Completion: April 20, 2026
• Study Completion (Estimated): November 4, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

TU (19); IT (21); DE (8); AU (3); GE (9); TW (9); KR (9); US (8); CL (4); FR (10); ES (19); MY (4)