Recruiting

Phase 2

FingolimodPhase 2 Study of Fingolimod in Lung Cancers

Sponsor:

Medical University of South Carolina

Code:

NCT06424067

Conditions

Non Small Cell Lung Cancer

Small-cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fingolimod 0.5 milligram (mg) [Gilenya]

Study Details

Brief summary:

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

Non Small Cell Lung Cancer

Small-cell Lung Cancer

Study ID

NCT06424067

Start date

May 1, 2025

Status verified date

Mar, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efficacy in NSCLC

n=22 NSCLC Any adult patients with lung cancer progressed on 2L+ systemic therapy n=any eligible patients from safety lead-in

experimental: Efficacy in SCLC

n=16 SCLC Any adult patients with lung cancer progressed on 2L+ systemic therapy n=any eligible patients from safety lead-in

Interventions

Fingolimod 0.5 milligram (mg) [Gilenya]

Oral fingolimod will be administered at a dose of 0.5 mg once a day.

Primary outcome measure

Safety of Fingolimod [ Time Frame: 6 months ]
Response Rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

HCC Clinical Trials Office

843-792-9321 hcc-clinical-trials@musc.edu

Locations

Hollings Cancer Center at Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

HCC Clinical Trials Office

843-792-9321 hcc-clinical-trials@musc.edu

Principal Investigator:

Mariam Alexander, MD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-03-30.