A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

February 10, 2026 updated by: Regeneron Pharmaceuticals

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned.

The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.

The study is also looking at several other research questions, including:

  • What are the side effects associated with the investigational treatments in comparison to the control treatment?
  • Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed?
  • How much of the study drug(s) are in the blood at a given time?
  • Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 01323-903
        • Recruiting
        • Hospital Alemao Oswaldo Cruz
    • Espírito Santo
      • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29306014
        • Recruiting
        • Oncology Clinical Research Center
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30380-472
        • Recruiting
        • Instituto Mario Penna
      • Pouso Alegre, Minas Gerais, Brazil, 37554-238
        • Recruiting
        • Instituto Sul Mineiro De Oncologia LTDA
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-902
        • Recruiting
        • Instituto de Medicina Integral Professor Fernando Figueira
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59060-195
        • Recruiting
        • Liga Norte Riograndense contra o cancer
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital Sao Lucas da PUCRS
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Recruiting
        • Hospital Mae de Deus Integrated Oncology Center
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88020-210
        • Recruiting
        • Ynova Pesquisa Clinica
    • São Paulo
      • Sorocaba, São Paulo, Brazil, 18065-100
        • Recruiting
        • Unimed Sorocaba
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • France
      • Bayonne, France, 64100
        • Recruiting
        • Centre Hospitalier de la Cote Basque
      • Bayonne, France, 64100
        • Recruiting
        • Clinique Belharra
      • Grenoble, France, 38330
        • Recruiting
        • CHU Grenoble Alpes
      • Montpellier, France, 34295
        • Recruiting
        • Montpellier Academic Hospital
    • Brittany Region
      • Rennes, Brittany Region, France, 35033
        • Recruiting
        • CHU Rennes
    • Var
      • Toulon, Var, France, 83055
        • Recruiting
        • Centre Hospitalier Intercommunal Toulon - CHITS
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75005
        • Recruiting
        • Institut Curie
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • University Hospital RWTH Aachen
    • Hesse
      • Kassel, Hesse, Germany, 34125
        • Recruiting
        • Klinikum Kassel GmbH, Hauttumorzentrum
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37083
        • Recruiting
        • University Medicine Gottingen
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University of Leipzig
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28033
        • Recruiting
        • MD Anderson Cancer Center
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clínico San Carlos
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico Universitario Valencia
      • Valencia, Spain, 46014
        • Recruiting
        • Consorci Hospital General Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Catalan Instituye of Oncology Badalona
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Valdecilla
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Universitario Insular de Gran Canaria
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34295
        • Recruiting
        • Florya Medical Park Hospital
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Detroit Clinical Research Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97213
        • Recruiting
        • University of Nebraska Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Lifespan Cancer Institute
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Recruiting
        • Prairie Lakes Healthcare System
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute (SCRI) Oncology Partners
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • BRCC/Oncology & Hematology Associates of SW Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. Adequate organ and bone marrow function, as described in the protocol

General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
  3. Presence of grade≥ 2 peripheral neuropathy
  4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

  1. Grade ≥3 hypercalcemia, as defined in the protocol
  2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chemotherapy+Cemiplimab
Control treatment
Drug: Cemiplimab
Intravenous (IV) infusion administration
Other Names:
  • REGN2810
  • LIBTAYO
Drug: Platinum-based chemotherapy
IV infusion
Experimental: Arm 1: Chemotherapy+Cemiplimab+REGN7075
Investigational Treatment
Drug: Cemiplimab
Intravenous (IV) infusion administration
Other Names:
  • REGN2810
  • LIBTAYO
Drug: Platinum-based chemotherapy
IV infusion
Drug: REGN7075
IV infusion
Other Names:
  • EGFRxCD28 bispecific immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 5 years
Up to 5 years
Pathologic complete response (pCR) rate as determined by central BIPR
Time Frame: Up to 12 weeks
Up to 12 weeks
Residual viable tumor (RVT) as determined by central BIPR
Time Frame: Up to 12 weeks
Up to 12 weeks
Objective response rate (ORR)
Time Frame: Up to 9 weeks
Up to 9 weeks
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 76 weeks
Up to 76 weeks
Severity of TEAEs
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of TEAEs leading to death
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of TEAEs leading to treatment discontinuation
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of adverse events of special interest (AESIs)
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of immune-mediated adverse events (imAEs)
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of infusion-related reactions (IRRs)
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of grade ≥3 laboratory abnormalities
Time Frame: Up to 76 weeks
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Up to 76 weeks
Proportion of delayed surgeries due to TEAEs
Time Frame: Up to 76 weeks
Up to 76 weeks
Proportion of cancelled surgeries due to TEAEs
Time Frame: Up to 76 weeks
Up to 76 weeks
Incidence of anti-drug antibodies (ADAs) to cemiplimab over time
Time Frame: Up to 67 weeks
Up to 67 weeks
Titer of ADAs to cemiplimab over time
Time Frame: Up to 67 weeks
Up to 67 weeks
Incidence of ADAs to novel anti-cancer agents over time
Time Frame: Up to 67 weeks
Up to 67 weeks
Titer of ADAs to novel anti-cancer agents over time
Time Frame: Up to 67 weeks
Up to 67 weeks
Median event-free survival (EFS)
Time Frame: Up to 5 years
Up to 5 years
EFS rate
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

May 2, 2030

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2810-ONC-2268
  • 2023-509806-31-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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