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

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. Par

Trial Details

NCT ID
NCT06088771
Phase
PHASE1 / PHASE2
Sponsor
Icahn School of Medicine at Mount Sinai
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Dupilumab
  • Cemiplimab
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings …
  • 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 S…
  • 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 perf…
  • Age ≥ 18 years.

For full eligibility, visit ClinicalTrials.gov.

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