Study on Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Duke University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06385262

This clinical trial is testing a combination of chemotherapy and the drug cemiplimab, with or without alirocumab, given before surgery to see if it can improve treatment outcomes for patients with certain stages of non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to find out if adding the drug alirocumab to a combination of chemotherapy and cemiplimab before surgery can make cancer cells more recognizable to the immune system, potentially leading to better treatment results in patients with specific stages of non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC).
  • Cancer must be at a stage that can be surgically removed (stages 1B, 2A, 2B, or 3A).
  • Primary tumor must be 3 cm or larger.
  • Agree to provide blood samples for research.
  • Must be a candidate for surgery.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • No previous treatments like chemotherapy or radiation for the current lung cancer diagnosis.
  • Have measurable disease according to specific criteria.
  • No active invasive cancer in the past 2 years, except for certain skin cancers.
  • Must sign a consent form and agree to the study's privacy guidelines.
  • Sexually active participants must use effective birth control during the study and for 120 days after the last dose.
  • Women of childbearing potential must test negative for pregnancy before starting the study.
  • Must have adequate organ function as shown by specific blood tests.

Exclusion Criteria

  • Currently in another study or have been in one recently.
  • Have specific genetic mutations related to lung cancer.
  • Have a history of active tuberculosis.
  • Allergic to alirocumab or its ingredients.
  • Receiving other cancer treatments.
  • Have had certain immune therapies before.
  • Have used an anti-PCSK9 drug recently.
  • Have active hepatitis B or C.
  • Unable to follow the study procedures.
  • Have an active infection needing treatment.
  • Have a history of lung inflammation not caused by infection.
  • Have uncontrolled HIV, hepatitis B, or C, unless well-managed.
  • Have an autoimmune disease needing treatment in the past 2 years.
  • Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
  • Have another progressing cancer needing treatment.
  • Pregnant or breastfeeding, or planning to conceive during the study.
  • Have had major surgery recently, except for lung cancer surgery.
  • Have had a live vaccine recently, except for certain flu or COVID-19 vaccines.
  • Have had a recent heart attack or have uncontrolled heart issues.
  • Have psychiatric or substance abuse issues affecting study participation.
  • Are a prisoner or involuntarily detained.

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