Cemiplimab + Dupilumab for Lung Cancer

(Dupi-Cemi Trial)

Overseen By Antoine Desilets, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Immunomodulatory drugs, Immunosuppressive drugs

Disqualifiers: Autoimmune disorders, Metastatic disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining cemiplimab (an immunotherapy drug) and dupilumab (a monoclonal antibody) is safe and effective for individuals with early-stage lung cancer that can be surgically removed. Researchers seek to assess whether the treatment can shrink tumors sufficiently before surgery and improve survival rates. The trial seeks participants with a history of smoking and lung cancer that doctors have confirmed or strongly suspect. Participants must agree to undergo blood tests and biopsies (small tissue samples) before starting the treatment. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for early-stage lung cancer.

Will I have to stop taking my current medications?

The trial requires that you stop using immunomodulatory drugs, including dupilumab, within 2 months before starting treatment. You also need to stop using immunosuppressive drugs or systemic steroids 7 days before treatment, except for chronic steroids at low doses.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cemiplimab is generally safe for treating advanced non-small cell lung cancer (NSCLC). Studies indicate that this drug, whether used alone or with other treatments, shows promise and is usually well-tolerated. Some patients might experience side effects like tiredness, skin rash, or diarrhea, but these are often manageable.

Dupilumab, also included in this trial, is known for treating asthma and eczema. It has a good safety record, with common side effects including reactions at the injection site and mild eye issues.

Combining cemiplimab and dupilumab is a newer approach, so the trial closely monitors for any serious side effects that could limit the dose. This careful observation helps identify any risks early on. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Cemiplimab and Dupilumab for lung cancer because it brings a fresh approach to treatment. Unlike standard therapies that often rely on chemotherapy or targeted drugs, this combination employs immunotherapy, which aims to boost the body's own immune system to fight cancer. Cemiplimab works by blocking PD-1, a protein that helps cancer cells evade immune detection, while Dupilumab targets the IL-4 and IL-13 pathways, which are involved in inflammation and could also play a role in cancer progression. By combining these two mechanisms, the treatment has the potential to be more effective in priming the immune system before surgery, offering hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that using cemiplimab and dupilumab together might help treat early-stage non-small cell lung cancer (NSCLC). In this trial, participants will receive a combination of cemiplimab and dupilumab as neoadjuvant therapy. Cemiplimab, when combined with chemotherapy, improved survival rates for people with advanced lung cancer, suggesting it could help the immune system fight cancer. Dupilumab blocks a specific part of the immune response, which might help control cancer growth. Early results suggest that using both drugs together could be a strong approach against lung cancer. This combination aims to improve outcomes by boosting the body's ability to attack cancer cells. ^{1 5 6 7 8}

Who Is on the Research Team?

Antoine Desilets, MD, MSc

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

This trial is for people with early-stage, operable non-small cell lung cancer (NSCLC). Participants should be eligible for surgery to remove the tumor and must not have received prior systemic therapy for NSCLC. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

My lung cancer diagnosis was confirmed with a tissue sample.

A team of doctors has approved me for surgery to remove my tumor.

I agree to have at least 3 needle biopsies as advised by my doctor.

Exclusion Criteria

I haven't needed systemic treatment for an autoimmune disease in the last year, except for hormone replacements like insulin or thyroxine.

HIV infection with detectable viral load or not on a stable HAART regimen

Active Hepatitis B or C (PCR-detectable)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive neoadjuvant cemiplimab and dupilumab to assess safety and feasibility using a 3+3 design to monitor dose-limiting toxicities

4 weeks

Weekly visits for monitoring

Phase 2a Treatment

Participants continue treatment to assess major pathological response (MPR) rate with a Simon's two-stage minimax design

Until day of surgery

Regular visits until surgery

Follow-up

Participants are monitored for safety, event-free survival, and overall survival after treatment and surgery

Up to 5 years

Periodic visits for long-term monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Dupilumab

Trial Overview The study tests combining two drugs, Cemiplimab (anti-PD-1) and Dupilumab (anti-IL-4Rα), before surgery in NSCLC patients. It's checking if this combo is safe (Phase 1b) and effective at causing a major response in the tumor tissue (Phase 2a).

How Is the Trial Designed?

Group I: Neoadjuvant cemiplimab and dupilumab combination therapy Experimental Treatment 2 Interventions

Neoadjuvant immunotherapy administered prior to thoracic surgery

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In patients with advanced non-small-cell lung cancer (NSCLC) and high PD-L1 expression (≥50%), cemiplimab showed significant improvements in progression-free survival (PFS) and objective response rate (ORR) compared to pembrolizumab, based on a systematic review and network meta-analysis of randomized-controlled trials.

Cemiplimab demonstrated comparable overall survival (OS) and similar safety profiles to pembrolizumab, indicating it is a viable first-line treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network meta-analysis of immune-oncology monotherapy as first-line treatment for advanced non-small-cell lung cancer in patients with PD-L1 expression ⩾50. Freemantle, N., Xu, Y., Wilson, FR., et al.[2022]

In a phase 3 study involving 710 patients with advanced non-small-cell lung cancer and high PD-L1 expression, cemiplimab significantly improved overall survival (not reached) and progression-free survival (8.2 months) compared to chemotherapy (14.2 months).

Cemiplimab also demonstrated a better safety profile, with fewer grade 3-4 treatment-emergent adverse events (28%) compared to chemotherapy (39%), making it a promising first-line treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Sezer, A., Kilickap, S., Gümüş, M., et al.[2022]

At 35 months of follow-up, patients with advanced non-small-cell lung cancer and high PD-L1 expression treated with cemiplimab had a median overall survival of 26.1 months, significantly better than the 13.3 months for those receiving chemotherapy, indicating a strong survival benefit from cemiplimab.

The addition of chemotherapy to cemiplimab after disease progression resulted in a median overall survival of 15.1 months, suggesting that this combination could be an effective second-line treatment option for patients with advanced non-small-cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial. Özgüroğlu, M., Kilickap, S., Sezer, A., et al.[2023]

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

Citations

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Libtayo® (cemiplimab) Plus Chemotherapy Results at Five ... Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-10539

Dupilumab and Cemiplimab for the Treatment of Early- ... This phase I/II trial tests the safety and efficacy of dupilumab and cemiplimab in treating patients with early stage non-small cell lung cancer that can be ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06743581

Phase I/II Study of Neoadjuvant Cemiplimab and ... 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 ...

4. globenewswire.com globenewswire.com/news-release/2025/09/09/3146733/0/en/Libtayo-cemiplimab-Plus-Chemotherapy-Results-at-Five-Years-Reinforce-Significant-and-Durable-Improvements-in-Survival-Outcomes-for-Advanced-Non-small-Cell-Lung-Cancer.html

Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall ...

5. mountsinai.org mountsinai.org/clinical-trials/neoadjuvant-dupilumab-cemiplimab-in-patients-with-early-stage-resectable-nsclc

Neoadjuvant Dupilumab and Cemiplimab in Patients With ... This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140711/

Safety, efficacy, and quality of life with cemiplimab ... Immune checkpoint inhibitors have shown promise in treating advanced non-small cell lung cancer and have a solid safety profile. Cemiplimab ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06743581

Phase I/​II Study of Neoadjuvant Cemiplimab and ... 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- ...

8. libtayohcp.com libtayohcp.com/nsclc/safety/monotherapy/follow-up-data

LIBTAYO safety profile in EMPOWER-Lung 1: 3-year data 1 Three year safety profile data in the EMPOWER-Lung 1 study for LIBTAYO in advanced NSCLC (non-small cell lung cancer). Review Important Safety Information and