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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT06743581
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab 350 mg administered intravenously on day 1
  • Dupilumab — DRUG
    Dupilumab 600 mg administered subcutaneously on day 1

Study Details

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.

Key Dates

First listed
Dec 20, 2024
Start date
Aug 19, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Feb 28, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant cemiplimab and dupilumab combination therapy
    Neoadjuvant immunotherapy administered prior to thoracic surgery

Primary Outcome Measure

Safety [ Time Frame: First 30 days after immunotherapy ]

Central Contacts

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