Early-stage Lung Cancer Study: Dupilumab and Cemiplimab Before Surgery
This study is looking at a new way to treat early-stage non-small cell lung cancer (NSCLC) that can be removed by surgery. It combines two medications, dupilumab and cemiplimab, given before your surgery. Researchers want to see how safe this combination is by tracking any side effects (toxicities) within 30 days after treatment. They also want to see how well the treatment shrinks the tumor before surgery (major pathological response). You may be able to join if you have a confirmed diagnosis of NSCLC and are able to have surgery, or if you have a history of smoking and imaging tests that strongly suggest NSCLC and are scheduled for a biopsy. This study plans to enroll 21 participants.
- Study design
- This is a Phase 1/2 interventional study, meaning it tests the safety and effectiveness of the combined treatment. It plans to enroll 21 participants.
- What's involved
- You would receive dupilumab and cemiplimab on Day 1. Your standard surgery would then be scheduled within 7 days of Day 15.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will track side effects for up to 30 days after treatment. Tumor response will be measured at the time of surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06088771
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
Recruiting
PHASE1Ages 18+InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~21 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:DupilumabCemiplimab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of dose limiting toxicities (DLTs)
Measured over up to 30 days post-treatment
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Thomas Marron, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings highly suggestive of a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy may be consented so as they can undergo the biopsy mandated for research at the same time to avoid second procedure. Pre-treatment biopsies are mandatory before treatment initiation. Patients with NSCLC must have T1b or more advanced (\>1cm primary tumor). Only patients whose tumor is deemed amenable to surgical or needle biopsy by a multidisciplinary team including a medical oncologist and an interventionalist (radiologist, surgeon, pulmonologist) may be enrolled.
Patient must be willing and able to provide blood samples (6 heparinized tubes, 2 streck tubes, roughly 60mL) at the time points indicated in the Study Calendar.
Patient must be willing and able to have core needle biopsies (Goal 3-6 biopsies, final number to be determined by the surgeon and radiologist performing the procedure as safe) of tumor prior to initiation of therapy.
Age ≥ 18 years.
ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy.
Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist.
Women of child-bearing potential and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Ability to understand and the willingness to sign a written informed consent.
Adequate organ and marrow function as defined below:
System/Laboratory Value
Hematologic:
Renal\* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for patient with creatinine levels \> 1.5 X institutional ULN Creatinine clearance should be calculated per institutional standard.
Hepatic\* Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN AST and ALT ≤ 2.5 X ULN Albumin \>2.5 mg/dL
Coagulation\* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants
Exclusion
Patients with history of autoimmune disorder or any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting treatment.
Patients without any smoking history, or any patient for whom we already have tissue or ctDNA evidence of an activating EGFR mutation or an ALK or ROS1 rearrangement.
Patients who have had chemotherapy or radiotherapy within 4 months prior to entering the study for a different primary tumor, nor can they have received locoregional therapy (e.g. radiation) for the target lesion that will be biopsied and subsequently resected. Previous therapy for a different cancer (a different primary) is acceptable.
Patients may not be receiving any other investigational agents.
Patients with metastatic disease, for whom the intent of surgery would not be curative.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements, as determined the treating investigator.
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Use of another immunomodulatory drug, including dupilumab, that may confound interpretation of clinical and biospecimen analysis, within 8 weeks of enrollment.
Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the administration of trial treatment. Patients on chronic steroids equivalent to ≤ 10mg prednisone will not be excluded.
Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
Has a known additional malignancy that is progressing and requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or anal cancer, prostate cancer on stable dose of hormonal therapy without rising PSA, and breast cancer whom have been treated with curative intent, who may be on hormonal therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen.
Has known active Hepatitis B (e.g., HBV detected by PCR (\>200 IU/ml) or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Patients whom have recently started (\>14d from C1D1) antiviral therapy may go on to the trial.
History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
Principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
Any evidence of current ILD or pneumonitis or a prior history of ILD or pneumonitis requiring oral or IV glucocorticoids.
What this trial measures
- Frequency of dose limiting toxicities (DLTs)up to 30 days post-treatment
Safety of treatment, defined as the frequency of dose limiting toxicities (DLTs), from start of treatment up to 30 days post the administration of dupilumab.
- Percentage of dose limiting toxicities (DLT)up to 30 days post-treatment
Safety of treatment, defined as the percentage of dose limiting toxicities (DLTs), from start of treatment up to 30 days post the administration of dupilumab.
- Major pathological response (MPR)Day of surgery, scheduled within 7 days of Day 15
Major pathological response (MPR), defined as the percentage of 90 percent or greater tumor necrosis at time of resection, as defined by expert thoracic pathologists.