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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests fingolimod, a drug typically used for multiple sclerosis, to determine its effectiveness for certain types of lung cancer—specifically non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC)—that have worsened after previous treatments. The study divides participants into two groups to assess fingolimod's effectiveness on each type of lung cancer. It may suit those who can take daily pills and have lung cancer unresponsive to other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early evidence of its potential benefits.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications if they interact with the study drug, fingolimod. Specifically, medications that affect heart rhythm or immune function might need to be changed or stopped. A doctor will review your medications before you start the trial.

Is there any evidence suggesting that fingolimod is likely to be safe for humans?

Research shows that fingolimod, the treatment under study for lung cancer, has been used for other health conditions. Real-world data from patients with relapsing-remitting multiple sclerosis (RRMS) indicate that fingolimod has generally been safe and well-tolerated over several years, with some side effects reported, though they are uncommon.

Early studies have shown that fingolimod has strong potential to slow or stop the growth of lung cancer cells. While this is encouraging, it is important to remember that the treatment is still being tested for lung cancer, and more information is needed to understand its safety in this new use.

Since this trial is in an early phase, large studies have not yet confirmed its safety for lung cancer patients. However, the treatment is not expected to have major safety issues, or the trial would not have been allowed to start. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard treatments for lung cancer, which generally include chemotherapy, radiation, and targeted therapies, Fingolimod offers a fresh approach by modulating the immune system. Originally used for multiple sclerosis, Fingolimod works by targeting sphingosine-1-phosphate receptors, potentially preventing cancer cells from evading the immune system. Researchers are excited because this novel mechanism could offer new hope for patients whose cancer has progressed despite other therapies, potentially leading to better outcomes with fewer side effects.

What evidence suggests that fingolimod might be an effective treatment for lung cancer?

Research has shown that fingolimod can induce a specific type of cell death in lung cancer cells, known as necroptosis. This process helps kill cancer cells by activating certain proteins that fight tumors. Studies suggest that fingolimod can slow tumor growth in both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) without causing severe side effects. In tests with mice, fingolimod effectively reduced tumor growth in NSCLC. Additionally, it enhances the body's immune response to cancer, working well with other treatments. In this trial, participants will be divided into two groups: one group will assess fingolimod's efficacy in SCLC, and the other will evaluate its efficacy in NSCLC. These findings support its potential effectiveness for patients whose cancer hasn't responded to other treatments. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06424067

Phase 2 Study of Fingolimod in Lung Cancers Fingolimod induces a type of programmed cell death called necroptosis in lung cancer cells. This is mediated by activation of the tumor suppressor protein ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9330228/

Therapeutic Potential of Fingolimod and Dimethyl ... These results suggest that Fingolimod and DMF affected tumor progression through different cellular mechanisms within the tumor microenvironment ...

3. mdpi.com mdpi.com/1422-0067/23/15/8192/review_report

Therapeutic Potential of Fingolimod and Dimethyl ... The authors have shown in basic experiments the effectiveness of fingolimod and DMF in inhibiting NSCLC cell proliferation. As stated by the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6605998/

Fingolimod augments Pemetrexed killing of non-small cell ... Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST ...

5. link.springer.com link.springer.com/article/10.1007/s00262-020-02693-7

Fingolimod and tumor-infiltrating lymphocytes in ... Given that ICIs invigorate exhausted effector T cells [15], their presence in solid tumors indicates an effective anti-tumor response.

6. careacross.com careacross.com/clinical-trials/trial/NCT06424067

Phase 2 Study of Fingolimod in Lung Cancers Fingolimod is a sphingosine analog that has demonstrated strong tumor suppressive activity in preclinical models of lung cancers and warrants further study.

7. nature.com nature.com/articles/s41467-023-39528-9

A landscape of response to drug combinations in non- ... Here we present a uniquely large dataset screening over 5000 targeted agent combinations across 81 non-small cell lung cancer cell lines.

8. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0267346&type=printable

The safety and efficacy of fingolimod: Real- world data from a ... Demographic, clinical, safety and efficacy data were analysed for up to 5 years from 570 consenting adult patients with RRMS who had received ...