Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rak płuca (niedrobnokomórkowy) lub silne podejrzenie na podstawie historii palenia i badań obrazowych
- •Wiek co najmniej 18 lat
- •Guz pierwotny większy niż 1 cm
- •Możliwość poddania się operacji usunięcia guza - potwierdzona przez zespół lekarzy
- •Możliwość pobrania próbek krwi (około 60 ml) zgodnie z harmonogramem badania
- •Możliwość pobrania próbek tkanki guza przed leczeniem
- •Dobre ogólne samopoczucie (stopień 0-1 wg skal medycznych)
- •Kobiety mogą uczestniczyć tylko jeśli stosują antykoncepcję przez całe badanie i 3 miesiące po
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, United States
Trial contact
Thomas Marron, MD, PhD
Katherine Vandris
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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