Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Trial end date:
2030-02-01
Target enrollment:
Participant gender:
Summary
This phase 1b/2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4R) 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.
Phase:
NA
Details
Lead Sponsor:
Centre hospitalier de l'Universit de Montral (CHUM)