Phase 2 Study of Fingolimod in Lung Cancers

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06424067
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fingolimod 0.5 milligram (mg) [Gilenya] — DRUG
    Oral fingolimod will be administered at a dose of 0.5 mg once a day.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Safety of Fingolimod [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321
Mariam Alexander, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charleston, SC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Hollings Cancer Center at Medical University of South Carolina· Charleston, SC

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