Phase 2 Study of Fingolimod in Lung Cancers
This study is testing a drug called fingolimod (Gilenya) in people with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) whose cancer has continued to grow despite previous chemotherapy and immunotherapy. Researchers want to see if fingolimod is safe and how well it works. Fingolimod is given as a 0.5 mg pill once a day. You may be able to join if you are 18 or older, have measurable cancer, and are willing to follow all study procedures. The study will measure the safety and how well the cancer responds to fingolimod over 6 months. The current recruitment status is unclear.
- Study design
- This is a single-institution, open-label Phase 2 study. It plans to enroll 38 participants, starting with a 6-patient safety lead-in, followed by two groups for effectiveness analysis.
- What's involved
- You would take oral fingolimod 0.5 mg once a day. You would need to comply with all study procedures and be available for the duration of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure safety and response rate at 6 months.
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NCT06424067
Phase 2 Study of Fingolimod in Lung Cancers
Recruiting
PHASE2Ages 18+InterventionalTreatmentMedical University of South CarolinaInvestigator-initiated
~38 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Fingolimod 0.5 milligram (mg) [Gilenya]
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of Fingolimod
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesSouth Carolina1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Baseline lymphocyte count \>1000 cells/mL
For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 2 months after the end of fingolimod administration.
For males of reproductive potential: use of condoms or other methods during and for an additional 2 months after the end of fingolimod treatment to ensure effective contraception with a partner.
Exclusion
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.
Patients who have a baseline QTc interval ≥ 500 msec
Patients who have cardiac arrhythmias requiring Class IA or Class III anti-arrhythmic drugs.
Class IA: disopyramide (Norpace), quinidine (Quinidex), procainamide (Procanbid)
Class III: dronedarone (Multaq), dofetilide (Tikosyn), sotalol (Betapace), ibutilide (Corvert), amiodarone (Nexterone)
Patients who have a hypersensitivity or allergic reaction (including rash, urticaria, and angioedema) to fingolimod or any of the excipients.
Patients who have an active, uncontrolled acute or chronic bacterial, viral, or fungal infection
Patients who have not completed all immunizations in accordance with current immunization guidelines before initiating fingolimod therapy
Unwillingness or inability to comply with procedures required in this protocol.
Patients who are currently participating in any other clinical trial of an investigational product
Female patients who are of child-bearing potential (WOCBP) who are pregnant, planning to become pregnant during the study, or lactating. A urine pregnancy test for WOCBP will be collected during the screening period. Females will be determined to be not of child-bearing potential with a history of hysterectomy, tubal ligation, or age 45 or older with postmenopausal status \> 12 months.
What this trial measures
- Safety of Fingolimod6 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
- Response Rate6 months
To evaluate the objective response rate (ORR) (when measurable) according to RECIST 1.1 criteria