RecruitingNot ApplicableNCT06743581

Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer

Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

24 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cemiplimab and a drug called Dupilumab for people with immunotherapy, neoadjuvant therapy, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

Cemiplimab 350 mg administered intravenously on day 1

DRUGDupilumab

Dupilumab 600 mg administered subcutaneously on day 1


Locations(2)

CHUM

Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

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NCT06743581


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