Dupilumab

Dupilumab will be administered at the recommended initial dosage of 600 mg (two 300 mg injections) on Day 1.

Cemiplimab will be administered at the recommended dosage of 350 mg, as an intravenous infusion, over 30 minutes on Day 1.

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.

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.

Registro actualizado en ClinicalTrials.gov →

• Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings highly suggestive of a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy may be consented so as they can undergo the biopsy mandated for research at the same time to avoid second procedure. Pre-treatment biopsies are mandatory before treatment initiation. Patients with NSCLC must have T1b or more advanced (>1cm primary tumor). Only patients whose tumor is deemed amenable to surgical or needle biopsy by a multidisciplinary team including a medical oncologist and an interventionalist (radiologist, surgeon, pulmonologist) may be enrolled.
• 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 Study Calendar.
• 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 performing the procedure as safe) of tumor prior to initiation of therapy.
• ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy.
• Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist.
• Women of child-bearing potential and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.