Phase 2 Study of Fingolimod for Lung Cancer Treatment
Sponsor: Medical University of South Carolina
ClinicalTrials ID:NCT06424067
This clinical trial is testing the safety and effectiveness of the drug fingolimod in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) who have not responded to previous treatments. Participants will take fingolimod orally once a day.
Patient Parameters
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Program Overview
This study aims to find out if fingolimod, a drug already used for multiple sclerosis, can help treat lung cancer. It focuses on patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) that have not improved with standard treatments like chemotherapy and immunotherapy. Fingolimod has shown promise in lab studies for stopping cancer growth and killing cancer cells. The trial will assess how safe and effective fingolimod is for these patients.
Description
Lung cancer is a common and serious disease, being the second most common cancer and the leading cause of cancer deaths in the U.S. Despite advances in treatment, patients with advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) often have poor outcomes after standard treatments fail. This study is exploring a new approach using fingolimod, a drug that has shown potential in lab studies to suppress tumor growth and kill cancer cells. Fingolimod is already approved for treating multiple sclerosis and works by affecting certain immune cells. In this trial, researchers will evaluate its safety and effectiveness in lung cancer patients who have not responded to other treatments. Participants will take fingolimod orally once a day, and the study will monitor their response to the treatment and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) that has not responded to at least two previous treatments.
- Able to take oral medication and willing to follow the fingolimod treatment plan.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have a baseline lymphocyte count greater than 1000 cells/mL.
- Women of childbearing potential must use effective birth control for at least one month before starting the study and continue during the study and for two months after.
- Men must use condoms or other methods during the study and for two months after to ensure effective contraception with a partner.
Exclusion Criteria
- Recent serious heart problems, such as a heart attack or stroke, within the last six months.
- Taking medications that interact strongly with fingolimod and cannot be safely stopped or switched.
- Have untreated brain metastases, unless previously treated and stable.
- Have certain heart rhythm problems unless a pacemaker is in place.
- Have a baseline QTc interval of 500 msec or more.
- Have a history of allergic reactions to fingolimod.
- Have active, uncontrolled infections.
- Have not completed all recommended vaccinations before starting fingolimod.
- Currently participating in another clinical trial.
- Women who are pregnant, planning to become pregnant, or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
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| Hollings Cancer Center at Medical University of South Carolina | 29425 | Charleston | South Carolina |
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