Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer (NCT06743581) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer
Canada24 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures.
* Age ≥ 18 years.
* ECOG performance status 0-1
* Determined to be a surgical candidate for tumor resection by a multidisciplinary team.
* Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately.
* Adequate organ and marrow function.
* Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\>1cm) and amenable to biopsy as determined by a multidisciplinary team.
* Patients must consent to provide blood at designated study time points.
* Patients must consent to core needle biopsies (at least 3 samples, as deemed safe by the performing surgeon/radiologist) prior to treatment initiation
Exclusion Criteria:
* History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation.
* Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin.
* Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent.
* No smoking history or confirmed tissue or ctDNA evidence of actionable drive…