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

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

Trial Details

NCT ID
NCT06743581
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Cemiplimab
  • Dupilumab
Locations (sample)
  • Montreal, Quebec, Canada|45.50884,-73.58781
  • Montreal, Quebec, Canada|45.50884,-73.58781

Key Eligibility Criteria

  • Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of N…
  • Age ≥ 18 years.
  • ECOG performance status 0-1
  • Determined to be a surgical candidate for tumor resection by a multidisciplinary team.

For full eligibility, visit ClinicalTrials.gov.

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