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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Cemiplimab 350 mg administered intravenously on day 1
Dupilumab 600 mg administered subcutaneously on day 1
CHUM
Montreal, Quebec, Canada
RECRUITINGCentre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
NOT_YET_RECRUITINGSafety
(Phase 1b) Safety (dose-limiting toxicities) of combined treatment with anti-IL-4R-alpha (dupilumab) and anti-PD-1 (cemiplimab) in patients with early-stage, resectable NSCLC.
Time frame: First 30 days after immunotherapy
Efficacy
(Phase 2a) Efficacy of combined cemiplimab and dupilumab in patients with early stage, resectable NSCLC. Efficacy is defined as percentage of patients achieving major pathological response (MPR), i.e. 90% or greater tumor necrosis at time of resection.
Time frame: Day of surgery
Rate of curative-intent surgery
(Phase 1b and 2a) Rate of curative-intent surgery following treatment intervention
Time frame: Day of surgery
Safety and Tolerability
(Phase 2a) Safety and tolerability in patients treated with dupilumab and cemiplimab treatment combination
Time frame: For up to 5 years or until death
Event-free survival (EFS)
(Phase 1b and 2a) Event free survival (EFS) as it relates to neoadjuvant cemiplimab and dupilumab treatment combination and following surgery
Time frame: For up to 5 years or until death
Overall survival (OS)
(Phase 1b and 2a) Overall survival (OS) as it relates to dupilumab and cemiplimab treatment combination and following surgery
Time frame: For up to 5 years or until death
Pathological complete response (pCR) rate
(Phase 1b and 2a) Assess pathological complete response (pCR) rate
Time frame: Day of surgery
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