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
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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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