Actively Recruiting
Phase 2 Study of Fingolimod in Lung Cancers
Led by Medical University of South Carolina · Updated on 2026-03-30
38
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Study of Fingolimod in Lung Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent according to institutional guidelines
- Willingness to comply with all study procedures and availability for the study duration
- Male or female participants
- 18 years of age or older
- Measurable or evaluable advanced/metastatic non-small cell lung cancer progressed on at least second-line systemic therapy
- Measurable or evaluable extensive stage small cell lung cancer progressed on at least second-line systemic therapy
- Ability to take oral medication and willingness to follow the fingolimod regimen
- ECOG performance status of 0 to 2
- Baseline lymphocyte count greater than 1000 cells/mL
- For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and during the study plus 2 months after treatment
- For males of reproductive potential: use of condoms or other contraception during and for 2 months after treatment
You will not qualify if you...
- Recent (within 6 months) serious cardiac events such as myocardial infarction, unstable angina, stroke, or heart failure requiring hospitalization
- Use of medications with major interactions with fingolimod that cannot be changed or stopped
- Concurrent use of QT-prolonging drugs with risk of torsade de pointes
- Concurrent use of drugs that slow heart rate or atrioventricular conduction
- Use of antineoplastic, immunosuppressive, or immune-modulating therapies concurrently
- Use of ketoconazole within 2 weeks before starting fingolimod
- Active untreated brain metastases; treated and stable brain metastases allowed
- History or presence of certain heart conduction disorders unless pacemaker is present
- Baseline QTc interval 500 msec or greater
- Use of certain class IA or III anti-arrhythmic drugs
- Allergic reaction to fingolimod or its ingredients
- Active, uncontrolled infection
- Incomplete immunizations per current guidelines
- Inability or unwillingness to comply with study procedures
- Participation in another clinical trial with an investigational product
- Female participants who are pregnant, planning pregnancy, or lactating; females not of child-bearing potential must have specific medical history or age criteria met
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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