Non-Small Cell Lung CancerDupi-CemiNCT06743581
Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer
A study testing Cemiplimab and Dupilumab in people with Non-Small Cell Lung Cancer and Immunotherapy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy
- What is being tested?
- Cemiplimab and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Aug 2025to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X 0A9
Anna Perez, 5148908000 ext. 31326, anna.perez.chum@ssss.gouv.qc.ca
Antoine Desilets, MD, MSc
- Not yet recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Antoine Desilets, MD, MSc, 514-890-8444, antoine.desilets.med@ssss.gouv.qc.ca
Wiam Belkaid, PhD, 514-836-3273 ext. 23242, wiam.belkaid.chum@ssss.gouv.qc.ca
About this study
Official title: 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.
- Being tested
- Cemiplimab, Dupilumab
- Keywords
- NSCLC, Neoadjuvant immunotherapy, Cemiplimab, Dupilumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Cemiplimab 350 mg administered intravenously on day 1
DupilumabDrug
Dupilumab 600 mg administered subcutaneously on day 1
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant cemiplimab and dupilumab combination therapy | Experimental | Neoadjuvant immunotherapy administered prior to thoracic surgery Receives: Drug: Cemiplimab; Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
(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.
Measured: First 30 days after immunotherapy
Efficacy
(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.
Measured: Day of surgery
Secondary outcomes (5)
Rate of curative-intent surgery
(Phase 1b and 2a) Rate of curative-intent surgery following treatment intervention
Measured: Day of surgery
Safety and Tolerability
(Phase 2a) Safety and tolerability in patients treated with dupilumab and cemiplimab treatment combination
Measured: For up to 5 years or until death
Event-free survival (EFS)
(Phase 1b and 2a) Event free survival (EFS) as it relates to neoadjuvant cemiplimab and dupilumab treatment combination and following surgery
Measured: For up to 5 years or until death
Overall survival (OS)
(Phase 1b and 2a) Overall survival (OS) as it relates to dupilumab and cemiplimab treatment combination and following surgery
Measured: For up to 5 years or until death
Pathological complete response (pCR) rate
(Phase 1b and 2a) Assess pathological complete response (pCR) rate
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start19 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Desilets, MD, MSc, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743581
- Sponsor's protocol ID
- 2025-12543
- Other IDs
- 2025
- Acronym
- Dupi-Cemi
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.
PubMed 38057662
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC
- ClinicalTrials.gov ID
- NCT06743581
- Acronym / sponsor ID
- Dupi-Cemi / 2025-12543
- Keywords
- NSCLC, Neoadjuvant immunotherapy, Cemiplimab, Dupilumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant cemiplimab and dupilumab combination therapy | Experimental | Drug: Cemiplimab, Drug: DupilumabNeoadjuvant immunotherapy administered prior to thoracic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabCemiplimab 350 mg administered intravenously on day 1 | Drug | Neoadjuvant cemiplimab and dupilumab combination therapy |
| DupilumabDupilumab 600 mg administered subcutaneously on day 1 | Drug | Neoadjuvant cemiplimab and dupilumab combination therapy |
Primary outcome
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.
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.
5 secondary outcomes
Rate of curative-intent surgery
Time frame: Day of surgery
Safety and Tolerability
Time frame: For up to 5 years or until death
Event-free survival (EFS)
Time frame: For up to 5 years or until death
Overall survival (OS)
Time frame: For up to 5 years or until death
Pathological complete response (pCR) rate
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 38057662LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine Desilets, MD, MSc principal investigator
CHUM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cemiplimab and Dupilumab in people with Non-Small Cell Lung Cancer and Immunotherapy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Desilets, MD, MSc (514-890-8444, antoine.desilets.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: First 30 days after immunotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.