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Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
This phase 1b/2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design. Secondary endpoints include event-free survival, overall survival, and translational objectives such as deep immune monitoring from patient samples, with the trial expected to enroll 24 patients at CHUM over five years.
Official title: Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-02-01
Completion Date
2030-02
Last Updated
2024-12-20
Healthy Volunteers
No
Interventions
Cemiplimab
Cemiplimab 350 mg administered intravenously on day 1
Dupilumab
Dupilumab 600 mg administered subcutaneously on day 1
Locations (1)
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada