Actively Recruiting
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-05-08
21
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1, participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per standard of care, outside the context of this clinical treatment, and undergo subsequent standard of care monitoring for recurrence. The study team will monitor the status of the participant through chart review, or by telephone should the patient not continue to follow with a physician at Mount Sinai, for up to 5 years.
CONDITIONS
Official Title
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of NSCLC or smoking history with imaging highly suggestive of NSCLC and scheduled diagnostic biopsy
- Tumor size T1b or larger (>1cm primary tumor)
- Tumor suitable for surgical or needle biopsy by a multidisciplinary team
- Willing and able to provide blood samples at specified times
- Willing and able to have 3-6 core needle biopsies of tumor before therapy
- Age 18 years or older
- ECOG performance status 0-1 or stable long-term disability unlikely to affect therapy response
- Determined to be surgical candidate by a multidisciplinary team
- Women of child-bearing potential and men agree to use adequate contraception during and 3 months after study
- Ability to understand and sign informed consent
- Adequate organ and marrow function as defined by specific blood and lab values
You will not qualify if you...
- History of autoimmune disorder or use of immunomodulatory drugs such as dupilumab within 8 weeks
- No smoking history or known activating EGFR mutation, ALK or ROS1 rearrangement
- Chemotherapy or radiotherapy within 4 months for a different primary tumor or locoregional therapy on target lesion
- Receiving any other investigational agents
- Metastatic disease without curative intent of surgery
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, or psychiatric/social issues limiting compliance
- Pregnant or nursing women
- Use of immunomodulatory drugs within 8 weeks potentially affecting results
- Primary immunodeficiency or systemic steroid or immunosuppressive therapy within 7 days prior to treatment
- Active autoimmune disease requiring systemic treatment in past year
- Known progressing additional malignancy requiring treatment except certain treated skin, cervical, anal, prostate, or breast cancers
- Conditions or therapies that may interfere with study participation or results
- HIV positive with detectable viral load or unstable anti-viral therapy
- Active Hepatitis B or C infection
- History of allogeneic hematopoietic or solid organ transplantation
- Allergic or hypersensitivity reaction to protein therapeutics
- Investigator judgment deeming patient unable to comply or not in best interest
- Current or prior interstitial lung disease or pneumonitis requiring steroids
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
T
Thomas Marron, MD, PhD
CONTACT
K
Katherine Vandris
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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