A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer
Medical University of South Carolina
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.
Description
Lung cancer is the second most common cancer and the leading cause of cancer death in the United States. There were approximately 237,000 new cases of lung cancer that were diagnosed in 2022 . The past decade has seen a revolution of new advances in the management of both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) with remarkable progress in screening, diagnosis, and treatment. The advances in systemic treatment have been driven primarily by the development of molecularly targeted therapeutics, immune-checkpoint inhibitors, and anti-angiogenic agents, all of which hav…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 extensiv…
Interventions
- DrugFingolimod 0.5 milligram (mg) [Gilenya]
Oral fingolimod will be administered at a dose of 0.5 mg once a day.
Location
- Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina