NCT06743581

Phase I/II 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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Immunotherapy
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Cemiplimab	Cemiplimab 350 mg administered intravenously on day 1
DRUG	Dupilumab	Dupilumab 600 mg administered subcutaneously on day 1

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2030-02-01
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: Canada