Fingolimod for Lung Cancer

Overseen By Alan Brisendine

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: QT-prolonging, Heart rate slowing, Antineoplastic, others

Disqualifiers: Recent cardiac event, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

38 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with advanced lung cancer (NSCLC or SCLC) that has worsened despite chemo-immunotherapy. Participants must have a baseline lymphocyte count over 1000 cells/mL, be able to take oral medication, and commit to the study's duration. They should not have severe heart issues, untreated brain metastases, or be on conflicting medications.

Inclusion Criteria

Voluntary, signed, and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines

I am either male or female.

Baseline lymphocyte count >1000 cells/mL

Exclusion Criteria

Patients who have a baseline QTc interval ≥ 500 msec

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

A 6 patient safety lead-in to assess the safety of fingolimod

6 weeks

Treatment

Participants receive fingolimod 0.5 mg orally once daily

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Fingolimod

Trial Overview The trial tests Fingolimod (Gilenya), taken orally once daily by patients with certain types of lung cancer who haven't responded well to previous treatments. It includes an initial safety assessment followed by efficacy analysis in two separate patient groups.

Participant Groups

Group I: Efficacy in SCLC Experimental Treatment 1 Intervention

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

Group II: Efficacy in NSCLC Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+