Phase 2 Study of Fingolimod in Lung Cancers

NCT06424067 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 103909
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety of Fingolimod

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.

  6 months

• Response Rate

  To evaluate the objective response rate (ORR) (when measurable) according to RECIST 1.1 criteria

  6 months

Secondary Outcomes (2)

• Progression-free Survival

  6 months

• Overall Survival

  6 months

Study Arms (2)

Efficacy in NSCLC

EXPERIMENTAL

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

Drug: Fingolimod 0.5 milligram (mg) [Gilenya]

Efficacy in SCLC

EXPERIMENTAL

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

Drug: Fingolimod 0.5 milligram (mg) [Gilenya]

Interventions

Fingolimod 0.5 milligram (mg) [Gilenya] DRUG

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

Efficacy in NSCLC; Efficacy in SCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

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.
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Central Study Contacts

HCC Clinical Trials Office

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)