Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using fingolimod to treat advanced lung cancers

Official title: A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer

Run by Medical University of South Carolina · NCT06424067 · Data updated 2026-11-12

This study is testing if fingolimod can safely help people with advanced lung cancer who haven't improved with other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment38 (estimated)
SponsorMedical University of South Carolina
Academic / other
Drugs / interventionsimmunotherapy, chemotherapy
Locations1 site (Charleston, South Carolina)
StatusRecruiting
StartedMay 1, 2025
Main results expectedMay 1, 2027
Study endsMay 1, 2028
Registry record updatedMarch 30, 2026
Trial IDNCT06424067 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with advanced NSCLC or extensive stage SCLC who have progressed on at least two lines of systemic therapy.

Probably not a fit

Patients with early-stage lung cancer or those who have not yet undergone chemotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of fingolimod in patients with advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) who have not responded to previous chemotherapy and immunotherapy. The study will begin with a safety lead-in involving six patients, followed by efficacy analysis in two cohorts receiving fingolimod orally at a dose of 0.5 mg once daily. Fingolimod, a sphingosine analog, has shown promising tumor suppressive activity in preclinical models, making it a candidate for further evaluation in lung cancer treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancers who have limited treatment choices.

How similar studies have gone: While fingolimod is primarily known for treating multiple sclerosis, its application in lung cancer is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

  • Hollings Cancer Center at Medical University of South Carolina
    Charleston, South Carolina, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.