NCT06088771

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

A Phase 1/2 Study of Combined Treatment With Dupilumab (Anti-IL-4Ra) and Cemiplimab (Anti-PD-1) in Patients With Early-stage, Resectable NSCLC

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Dupilumab	Dupilumab will be administered at the recommended initial dosage of 600 mg (two 300 mg injections) on Day 1.
BIOLOGICAL	Cemiplimab	Cemiplimab will be administered at the recommended dosage of 350 mg, as an intravenous infusion, over 30 minutes on Day 1.

Timeline

• Start date: 2024-03-08
• Primary completion: 2026-04-15
• Completion: 2027-04-22
• First posted: 2023-10-18
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study