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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06088771
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 8, 2024
Status verified
Apr 2025
Primary completion
Apr 15, 2026
Completion
Apr 22, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non-small-cell lung cancer (NSCLC)
    Participants will receive neoadjuvant subcutaneous Dupilumab 600mg and intravenous Cemiplimab 350mg on Day 1. Participants will proceed to standard of care surgery for early-stage, resectable NSCLC (within 7 days of Day 15), and will be observed for adverse events and dose limiting toxicities.

Primary Outcome Measure

Frequency of dose limiting toxicities (DLTs) [ Time Frame: up to 30 days post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Thomas Marron, MD PhD
[email protected]
(212) 824-9472
Katherine Vandris
[email protected]
Thomas Marron, MD (PRINCIPAL_INVESTIGATOR)

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By condition
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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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