Non Small Cell Lung CancerPhase 2NCT06424067
Phase 2 Study of Fingolimod in Lung Cancers
A Phase 2 study testing Fingolimod 0.5 milligram (mg) [Gilenya] in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- What is being tested?
- Fingolimod 0.5 milligram (mg) [Gilenya]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 extensive stage small cell lung cancer progressed on 2L+ systemic therapy.
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- 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.
Who cannot join
- 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.
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- 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
- 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
- Female patients who are of child-bearing potential (WOCBP) who are pregnant, planning to become pregnant during the study, or lactating. A urine pregnancy test for WOCBP will be collected during the screening period. Females will be determined to be not of child-bearing potential with a history of hysterectomy, tubal ligation, or age 45 or older with postmenopausal status > 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
HCC Clinical Trials Office, 843-792-9321, hcc-clinical-trials@musc.edu
Mariam Alexander, MD
About this study
Official title: A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer
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.
Read the detailed 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 have transformed this field with significantly improved patient outcomes. Despite these advances, the prognosis for patients with advanced NSCLC and SCLC is poor, particularly after the failure of a platinum-based chemotherapy regimen and check point inhibitors with limited options available for patients. Therefore, new methods of targeting these malignancies are crucial. Fingolimod is a sphingosine analog that has demonstrated strong tumor suppressive activity in preclinical models of lung cancers and warrants further study.
This proposed study is a single institution Phase II clinical trial to investigate the safety and efficacy of fingolimod in patients with NSCLC and SCLC. Fingolimod is a small molecule derived from myriocin that acts as a sphingosine analog. It is currently FDA-approved to treat patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease by binding to sphingosine-1-phosphate (S1P) receptors 1, 3, 4, and 5 causing T lymphocyte egression and retention in peripheral lymphoid organs leading to immunosuppression. However, it can act as an antagonist for the S1P receptor promoting tumor suppression in multiple cancer cell lines and mouse models inhibiting cell proliferation, and inducing cancer cell death. There are multiple studies demonstrating its activity in preclinical models of lung cancer. Fingolimod induces a type of programmed cell death called necroptosis in lung cancer cells. This is mediated by activation of the tumor suppressor protein phosphatase 2A (PP2A) through interaction with the PP2A inhibitor (I2PP2A). Specifically, work done using the adenocarcinoma cell line A549 and small cell carcinoma cell line H1341 showed that fingolimod-mediated stress induced the formation of ceramidosomes leading to plasma membrane blebbing, compromised membrane integrity, and necroptosis.
This study will evaluate the safety, tolerability, and response rate in patients with NCSLC and SCLC who have progressed on front-line therapy including chemotherapy, immune checkpoint inhibitors, and targeted agents. It will contribute to the development of new methods for targeting these malignancies and provide insights into the potential use of fingolimod as a treatment option for these patients.
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Being tested
- Fingolimod 0.5 milligram (mg) [Gilenya]
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingolimod 0.5 milligram (mg) [Gilenya]Drug
Oral fingolimod will be administered at a dose of 0.5 mg once a day.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Fingolimod 0.5 milligram (mg) [Gilenya] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Fingolimod
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Measured: 6 months
Response Rate
To evaluate the objective response rate (ORR) (when measurable) according to RECIST 1.1 criteria
Measured: 6 months
Secondary outcomes (2)
Progression-free Survival
Progression-free survival (PFS) as measured from the date of the first study treatment to the date of the first objective documentation of radiographic disease progression or death due to any cause
Measured: 6 months
Overall Survival
Overall survival (OS) as measured from the date of first study treatment to the date of death due to any cause
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424067
- Sponsor's protocol ID
- 103909
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06424067
- Acronym / sponsor ID
- 103909
- Conditions
- Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 have transformed this field with significantly improved patient outcomes. Despite these advances, the prognosis for patients with advanced NSCLC and SCLC is poor, particularly after the failure of a platinum-based chemotherapy regimen and check point inhibitors with limited options available for patients. Therefore, new methods of targeting these malignancies are crucial. Fingolimod is a sphingosine analog that has demonstrated strong tumor suppressive activity in preclinical models of lung cancers and warrants further study.
This proposed study is a single institution Phase II clinical trial to investigate the safety and efficacy of fingolimod in patients with NSCLC and SCLC. Fingolimod is a small molecule derived from myriocin that acts as a sphingosine analog. It is currently FDA-approved to treat patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease by binding to sphingosine-1-phosphate (S1P) receptors 1, 3, 4, and 5 causing T lymphocyte egression and retention in peripheral lymphoid organs leading to immunosuppression. However, it can act as an antagonist for the S1P receptor promoting tumor suppression in multiple cancer cell lines and mouse models inhibiting cell proliferation, and inducing cancer cell death. There are multiple studies demonstrating its activity in preclinical models of lung cancer. Fingolimod induces a type of programmed cell death called necroptosis in lung cancer cells. This is mediated by activation of the tumor suppressor protein phosphatase 2A (PP2A) through interaction with the PP2A inhibitor (I2PP2A). Specifically, work done using the adenocarcinoma cell line A549 and small cell carcinoma cell line H1341 showed that fingolimod-mediated stress induced the formation of ceramidosomes leading to plasma membrane blebbing, compromised membrane integrity, and necroptosis.
This study will evaluate the safety, tolerability, and response rate in patients with NCSLC and SCLC who have progressed on front-line therapy including chemotherapy, immune checkpoint inhibitors, and targeted agents. It will contribute to the development of new methods for targeting these malignancies and provide insights into the potential use of fingolimod as a treatment option for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efficacy in NSCLC | Experimental | Drug: Fingolimod 0.5 milligram (mg) [Gilenya]n=22 NSCLC Any adult patients with lung cancer progressed on 2L+ systemic therapy n=any eligible patients from safety lead-in |
| Efficacy in SCLC | Experimental | Drug: Fingolimod 0.5 milligram (mg) [Gilenya]n=16 SCLC Any adult patients with lung cancer progressed on 2L+ systemic therapy n=any eligible patients from safety lead-in |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingolimod 0.5 milligram (mg) [Gilenya]Oral fingolimod will be administered at a dose of 0.5 mg once a day. | Drug | Efficacy in NSCLC, Efficacy in SCLC |
Primary outcome
Safety of Fingolimod
Time frame: 6 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Response Rate
Time frame: 6 months
To evaluate the objective response rate (ORR) (when measurable) according to RECIST 1.1 criteria
2 secondary outcomes
Progression-free Survival
Time frame: 6 months
Overall Survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fingolimod 0.5 milligram (mg) [Gilenya] in people with Non Small Cell Lung Cancer and Small-cell Lung Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Fingolimod (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.