Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer (Dupi-Cemi)

August 13, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • CHUM
        • Principal Investigator:
          • Antoine Desilets, MD, MSc
        • Contact:
      • Montreal, Quebec, Canada, H2X 3E4
        • Not yet recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoine Desilets, MD, MSc
        • Sub-Investigator:
          • Moishe Liberman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant cemiplimab and dupilumab combination therapy
Neoadjuvant immunotherapy administered prior to thoracic surgery
Drug: Cemiplimab
Cemiplimab 350 mg administered intravenously on day 1
Drug: Dupilumab
Dupilumab 600 mg administered subcutaneously on day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: First 30 days after immunotherapy
(Phase 1b) Safety (dose-limiting toxicities) of combined treatment with anti-IL-4R-alpha (dupilumab) and anti-PD-1 (cemiplimab) in patients with early-stage, resectable NSCLC.
First 30 days after immunotherapy
Efficacy
Time Frame: Day of surgery
(Phase 2a) Efficacy of combined cemiplimab and dupilumab in patients with early stage, resectable NSCLC. Efficacy is defined as percentage of patients achieving major pathological response (MPR), i.e. 90% or greater tumor necrosis at time of resection.
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR) rate
Time Frame: Day of surgery
(Phase 1b and 2a) Assess pathological complete response (pCR) rate
Day of surgery
Rate of curative-intent surgery
Time Frame: Day of surgery
(Phase 1b and 2a) Rate of curative-intent surgery following treatment intervention
Day of surgery
Safety and Tolerability
Time Frame: For up to 5 years or until death
(Phase 2a) Safety and tolerability in patients treated with dupilumab and cemiplimab treatment combination
For up to 5 years or until death
Event-free survival (EFS)
Time Frame: For up to 5 years or until death
(Phase 1b and 2a) Event free survival (EFS) as it relates to neoadjuvant cemiplimab and dupilumab treatment combination and following surgery
For up to 5 years or until death
Overall survival (OS)
Time Frame: For up to 5 years or until death
(Phase 1b and 2a) Overall survival (OS) as it relates to dupilumab and cemiplimab treatment combination and following surgery
For up to 5 years or until death

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of recurrence ahead of radiographic evidence of recurrence
Time Frame: Day 1, Day 4, Day 8, Day 15, Day of surgery and Day 30 and at recurrence if applicable
The creation of dynamic atlases documenting the evolution of a patient's TME, comparing pre-treatment biopsy and blood with subsequent tumor resection and blood collection. The formation of this atlas involves histologic, immunologic, genetic and radiomic characterization of the tumor both in bulk and at the single cell level, across time (from pre-treatment biopsy to biopsy upon recurrence) and across patients, and potentially even organ specific cohorts. ctDNA will be measured at multiple time points during treatment using an investigational available assay, and the ability of this assay to detect recurrence ahead of radiographic evidence of recurrence measured.
Day 1, Day 4, Day 8, Day 15, Day of surgery and Day 30 and at recurrence if applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Antoine Desilets, MD, MSc, CHUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-12543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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