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)
NCT ID: NCT06465329
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-11-18
2030-05-02
Brief Summary
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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)?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy+Cemiplimab
Control treatment
Cemiplimab
Intravenous (IV) infusion administration
Platinum-based chemotherapy
IV infusion
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Investigational Treatment
Cemiplimab
Intravenous (IV) infusion administration
Platinum-based chemotherapy
IV infusion
REGN7075
IV infusion
Interventions
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Cemiplimab
Intravenous (IV) infusion administration
Platinum-based chemotherapy
IV infusion
REGN7075
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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 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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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University of California Irvine
Orange, California, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Hospital Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario Valencia
Valencia, , Spain
Karmanos Cancer Institute
Detroit, Michigan, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Providence Portland Medical Center
Portland, Oregon, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Oncology Clinical Research Center
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
CHU Rennes
Rennes, Brittany Region, France
Centre Hospitalier Intercommunal Toulon - CHITS
Toulon, Var, France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Clinique Belharra
Bayonne, , France
CHU Grenoble Alpes
Grenoble, , France
Montpellier Academic Hospital
Montpellier, , France
Institut Curie
Paris, Île-de-France Region, France
Klinikum Kassel GmbH, Hauttumorzentrum
Kassel, Hesse, Germany
University Medicine Gottingen
Göttingen, Lower Saxony, Germany
University of Leipzig
Leipzig, Saxony, Germany
University Hospital RWTH Aachen
Aachen, , Germany
Hospital Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Consorci Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Clinico Lozano Blesa
Zaragoza, , Spain
Florya Medical Park Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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2023-509806-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R2810-ONC-2268
Identifier Type: -
Identifier Source: org_study_id
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