Study on Neoadjuvant Dupilumab and Cemiplimab for Early-stage Resectable Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06088771

Provider View

This clinical trial is testing a combination of two drugs, dupilumab and cemiplimab, to see if they can help treat early-stage non-small cell lung cancer (NSCLC) before surgery. The study involves patients who are candidates for surgery or those with a smoking history and signs of NSCLC.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. The treatment involves two drugs: dupilumab, which targets a specific immune pathway, and cemiplimab, which helps the immune system attack cancer cells. Participants will receive these drugs before undergoing surgery to remove the cancer. The study will monitor participants for any side effects and assess the treatment's safety and effectiveness. After surgery, participants will continue with standard follow-up care and monitoring for up to five years.

Eligibility Criteria

Exclusion Criteria

  • History of autoimmune disorders or use of immune-modulating drugs like dupilumab within 8 weeks before starting the study.
  • No smoking history or evidence of specific genetic mutations in the cancer.
  • Recent chemotherapy or radiation for another cancer within 4 months before the study.
  • Currently taking other experimental treatments.
  • Cancer that has spread beyond the lungs, where surgery would not be curative.
  • Uncontrolled illnesses, such as infections needing antibiotics, heart failure, or psychiatric conditions that could affect participation.
  • Pregnant or nursing women due to potential risks to the baby.
  • Use of immune-modulating drugs within 8 weeks before the study.
  • Primary immune deficiency or use of steroids or other immune-suppressing drugs within 7 days before treatment.
  • Active autoimmune disease needing treatment in the past year.
  • Other progressing cancers needing treatment, except for certain skin cancers or stable prostate or breast cancer.
  • Conditions or treatments that could interfere with the study or are not in the patient's best interest.
  • HIV positive with detectable viral load or not on stable antiviral treatment.
  • Active Hepatitis B or C infections.
  • Recent start of antiviral therapy.
  • History of organ or bone marrow transplants.
  • Allergic reactions to protein-based treatments.
  • Investigator believes the patient cannot comply with study requirements or the trial is not in the patient's best interest.
  • Current or past lung conditions like interstitial lung disease or pneumonitis needing treatment.

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