OncoMatch/Clinical Trials/NCT06088771
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
Is NCT06088771 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dupilumab and Cemiplimab for non-small cell lung cancer.
Treatment: Dupilumab · Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: ALK rearrangement
Excluded: EGFR activating mutation
Excluded: ROS1 rearrangement
Disease stage
Required: Stage T1B OR MORE ADVANCED (TNM)
Patients with NSCLC must have T1b or more advanced (>1cm primary tumor)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: for a different primary tumor is acceptable
Patients who have had chemotherapy ... within 4 months prior to entering the study for a different primary tumor, nor can they have received locoregional therapy (e.g. radiation) for the target lesion that will be biopsied and subsequently resected. Previous therapy for a different cancer (a different primary) is acceptable.
Cannot have received: radiotherapy
Exception: for a different primary tumor is acceptable
Patients who have had ... radiotherapy within 4 months prior to entering the study for a different primary tumor, nor can they have received locoregional therapy (e.g. radiation) for the target lesion that will be biopsied and subsequently resected. Previous therapy for a different cancer (a different primary) is acceptable.
Cannot have received: immunomodulatory drug (dupilumab)
any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting treatment
Lab requirements
Blood counts
ANC ≥1,000 /mcL; Platelets ≥75,000 /mcL; Hemoglobin ≥9 g/dL
Kidney function
Serum creatinine ≤1.5 X ULN OR measured/calculated creatinine clearance (GFR can also be used) ≥60 mL/min for patient with creatinine levels > 1.5 X ULN
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 X ULN; Albumin >2.5 mg/dL
Adequate organ and marrow function as defined below: Hematologic: ANC ≥1,000 /mcL Platelets ≥75,000 /mcL Hemoglobin ≥9 g/dL; Renal: Serum creatinine ≤1.5 X ULN OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for patient with creatinine levels > 1.5 X institutional ULN; Hepatic: Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN AST and ALT ≤ 2.5 X ULN Albumin >2.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
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