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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)

NCT06465329 · Regeneron Pharmaceuticals
In plain English

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Official title
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
About this study
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)?
Eligibility criteria
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 design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-18
Estimated completion: 2030-05-02
Last updated: 2026-02-12
Interventions
Drug: CemiplimabDrug: Platinum-based chemotherapyDrug: REGN7075
Primary outcomes
  • Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR) (Up to 12 weeks)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (49)
University of California IrvineRecruiting
Orange, California, United States
Orchard Healthcare Research Inc.Recruiting
Skokie, Illinois, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Detroit Clinical Research CenterRecruiting
Farmington Hills, Michigan, United States
Morristown Medical CenterRecruiting
Morristown, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
University Of Nebraska Medical CenterRecruiting
Portland, Oregon, United States
Lifespan Cancer InstituteRecruiting
Providence, Rhode Island, United States
Prairie Lakes Healthcare SystemRecruiting
Watertown, South Dakota, United States
University of Tennessee Medical CenterRecruiting
Knoxville, Tennessee, United States
Sarah Cannon Research Institute (SCRI) Oncology PartnersRecruiting
Nashville, Tennessee, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
BRCC/Oncology & Hematology Associates of SW VirginiaRecruiting
Blacksburg, Virginia, United States
Oncology Clinical Research CenterRecruiting
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Instituto Mario PennaRecruiting
Belo Horizonte, Minas Gerais, Brazil
Instituto Sul Mineiro De Oncologia LTDARecruiting
Pouso Alegre, Minas Gerais, Brazil
Instituto de Medicina Integral Professor Fernando FigueiraRecruiting
Recife, Pernambuco, Brazil
Liga Norte Riograndense Contra o CancerRecruiting
Natal, Rio Grande do Norte, Brazil
Hospital Mae de Deus Integrated Oncology CenterRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRSRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Ynova Pesquisa ClinicaRecruiting
Florianópolis, Santa Catarina, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoRecruiting
São José do Rio Preto, São Paulo, Brazil
Unimed SorocabaRecruiting
Sorocaba, São Paulo, Brazil
Hospital Alemao Oswaldo CruzRecruiting
São Paulo, Brazil
CHU RennesRecruiting
Rennes, Brittany Region, France
Centre Hospitalier Intercommunal Toulon - CHITSRecruiting
Toulon, Var, France
Centre Hospitalier de la Cote BasqueRecruiting
Bayonne, France
Clinique BelharraRecruiting
Bayonne, France
CHU Grenoble AlpesRecruiting
Grenoble, France
Montpellier Academic HospitalRecruiting
Montpellier, France
Institut CurieRecruiting
Paris, Île-de-France Region, France
Klinikum Kassel GmbH, HauttumorzentrumRecruiting
Kassel, Hesse, Germany
University Medicine GottingenRecruiting
Göttingen, Lower Saxony, Germany
University of LeipzigRecruiting
Leipzig, Saxony, Germany
University Hospital RWTH AachenRecruiting
Aachen, Germany
Catalan Instituye of Oncology BadalonaRecruiting
Badalona, Barcelona, Spain
Hospital ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Universitario Insular de Gran CanariaRecruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Navarre, Spain
MD Anderson Cancer CenterRecruiting
Madrid, Spain
Hospital Universitario Clinico San CarlosRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
Hospital Virgen del RocioRecruiting
Seville, Spain
Hospital Clinico Universitario ValenciaRecruiting
Valencia, Spain
Consorci Hospital General Universitario de ValenciaRecruiting
Valencia, Spain
Hospital Clinico Lozano BlesaRecruiting
Zaragoza, Spain
Florya Medical Park HospitalRecruiting
Istanbul, Turkey (Türkiye)
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) · TrialPath