Neoadjuvant Cemiplimab + Dupilumab in Early-Stage NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1b/2a trial to test safety, feasibility, and preliminary effectiveness of combining cemiplimab (a PD-1 inhibitor) with dupilumab (an IL-4Rα blocker) before surgical resection of resectable NSCLC. The trial uses a 3+3 design in the first part to monitor dose-limiting toxicities, and a Simon two-stage design in the second part to evaluate major pathological response rates. Secondary goals include event-free and overall survival, plus translational studies with deep immune monitoring from patient samples. About 24 patients are planned to enroll at CHUM over five years.

Why it matters

Who can join: the full rules

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 driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements)
* Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable.
* Metastatic disease where surgery would not have curative intent.
* Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric/social conditions impeding study compliance.
* Pregnancy or nursing, due to potential harm to the fetus or infant.
* Progressive malignancy requiring active treatment, except for certain stable cancers treated with curative intent
* HIV infection with detectable viral load or not on a stable HAART regimen
* Active Hepatitis B or C (PCR-detectable)
* History of allogeneic hematopoietic or solid organ transplantation.
* Documented hypersensitivity to protein therapeutics.
* Any condition, therapy, or abnormality that may interfere with trial results, patient participation, or their best interest as per the investigator's judgment.

Where it's running

• Chum
  Montreal, Quebec, Canada Recruiting
• Centre hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Antoine Desilets, MD, MSc — Chum
• Study coordinator: Antoine Desilets, MD, MSc
• Email: antoine.desilets.med@ssss.gouv.qc.ca
• Phone: 514-890-8444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.