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NCT06743581 · ClinicalTrials.gov record · last posted 2026-08-17

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

Study acronym: Dupi-Cemi
StatusRecruiting
PhaseNot applicable
Started2025-08-19
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-18
Recruitment opened
2026-08-18
Primary endpoint(s) modified
WasMajor pathological response (MPR) rate, Safety
NowEfficacy, Safety
2026-08-18
Primary completion pushed: 2027-02 → 2027-12
Trial Details
NCT Number NCT06743581
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy
Enrollment 24 participants
Start Date 2025-08-19
Primary Completion 2027-12 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-17