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)

Part of paid clinical trials in Orange, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06465329
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Intravenous (IV) infusion administration
  • Platinum-based chemotherapy — DRUG
    IV infusion
  • REGN7075 — DRUG
    IV infusion

Study Details

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)?

Key Dates

Start date
Nov 18, 2024
Status verified
May 2025
Primary completion
May 20, 2027
Completion
May 2, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Chemotherapy+Cemiplimab
    Control treatment
  • Experimental: Arm 1: Chemotherapy+Cemiplimab+REGN7075
    Investigational Treatment

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868-
Orchard Healthcare Research Inc.SkokieIllinois60077-
Karmanos Cancer InstituteDetroitMichigan48201-
Detroit Clinical Research CenterFarmington HillsMichigan48334-
Morristown Medical CenterMorristownNew Jersey07960-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Providence Portland Medical CenterPortlandOregon97213-
University Of Nebraska Medical CenterPortlandOregon97213-
Lifespan Cancer InstituteProvidenceRhode Island02903-
Prairie Lakes Healthcare SystemWatertownSouth Dakota57201-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Sarah Cannon Research Institute (SCRI) Oncology PartnersNashvilleTennessee37203-
Tennessee OncologyNashvilleTennessee37203-
BRCC/Oncology & Hematology Associates of SW VirginiaBlacksburgVirginia24060-

Find similar trials in Orange, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California Irvine· Orange, CAOrchard Healthcare Research Inc.· Skokie, ILKarmanos Cancer Institute· Detroit, MIDetroit Clinical Research Center· Farmington Hills, MIMorristown Medical Center· Morristown, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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