RecruitingNon Small Cell Lung CancerSmall-cell Lung Cancer
Phase 2 Study of Fingolimod in Lung Cancers
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This is a single-institution, open-labeled study using fingolimod (FTY720/Gilenya) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) who have progressed on chemo-immunotherapy. The study design will be a 6 patient safety lead-in with 2 cohorts of patients for efficacy analysis where fingolimod 0.5 mg will be taken orally once daily.
Sponsor: Medical University of South Carolina
You may qualify if…
- ✓ Voluntary, signed, and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.
- ✓ Stated willingness to comply with all study procedures and availability for the duration of the study.
- ✓ Male or female
- ✓ 18 years of age or older
- ✓ Measurable/evaluable as defined by RECIST 1.1 at baseline of advanced/metastatic non-small cell lung cancer progressed on 2L+ systemic therapy with any molecular subtype and PD-L1 Tumor Proportion Score (TPS).
- ✓ Measurable/evaluable as defined by RECIST 1.1 at baseline of extensive stage small cell lung cancer progressed on 2L+ systemic therapy.
- ✓ Ability to take oral medication and be willing to adhere to the fingolimod regimen.
- ✓ ECOG performance status 0-2
You may not qualify if…
- ✕ Patients who have had a recent (within the last 6 months) occurrence of cardiac event including myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or New York Heart Association Class III or IV heart failure, and congenital long QT-syndrome
- ✕ Patients who are receiving any medication(s) identified as having a Category D or higher interaction with the identified study agent who cannot be switched to another agent or discontinued before treatment if clinically appropriate. This medication review will be conducted by an oncology-trained Doctor of Pharmacy and discussed with the investigators before starting the treatment phase of this study. Careful evaluation for the following class of medications should be warranted due to their potential for severe side effects:
- ✕ Concurrent therapy with QT-prolonging medications with a known risk of torsade de pointes
- ✕ Concurrent therapy with drugs that slow heart rate or atrioventricular conduction
- ✕ Concurrent therapy with antineoplastic, immunosuppressive, or immune-modulating therapies
- ✕ Patients taking ketoconazole who have not completed their last dose at least 2 weeks before starting fingolimod.
- ✕ Active untreated brain metastases. Patients are eligible if brain metastases are previously treated and are asymptomatic. Patients must be neurologically stable and must be on stable or tapering corticosteroids 2 weeks before Cycle 1 Day 1
- ✕ Patients who have a history or presence of Mobitz Type II 2nd-degree or 3rd-degree atrioventricular block or sick sinus syndrome, unless patients have a functioning pacemaker.
Where it's recruiting
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT06424067 · last updated 2026-03-30