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Fasting-Mimicking Diet with Immunotherapy for Stage IV NSCLC

This study is looking at how a special plant-based diet, called a Fasting-Mimicking Diet (FMD), works with immunotherapy (a treatment that helps your body's immune system fight cancer) for people with Stage IV non-small cell lung cancer (NSCLC). Researchers want to see if the FMD can make immunotherapy more effective and reduce side effects. You would receive standard immunotherapy, and some participants will also follow the FMD for certain cycles. The study is open to adults aged 18 and older who have newly diagnosed Stage IV NSCLC and an ECOG performance status of 0 to 2. The main goals are to see if the FMD is practical to follow and if people stick with it. The current recruitment status is unclear, and 66 people are planned to enroll.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 66 participants, but the phase of the study is not specified.
What's involved
Patients will eat a regular diet with the first 3 cycles of immunotherapy, then receive 3 cycles of the Fasting-Mimicking Diet as they continue cycles 4-6 of immunotherapy.
Compensation
Not stated in the trial record.
Follow-up
The feasibility and compliance of the diet intervention will be measured through study completion, up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06671613

Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer

Recruiting
NAAges 18+InterventionalSupportive care
VA Office of Research and Development
~66 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:FMDRegular Diet Plus FMD

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of fasting mimicking diet intervention
Measured over Through study completion up to 2 years.
+1 more outcome measured

Conditions

Stage IV NSCLC
NSCLC
Immunotherapy
Fasting Mimicking Diet

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Where it's being run

4 sites across 4 states
California1
Illinois1
Indiana1
Missouri1

Study leadership

  • Shadia Jalal, MD · PRINCIPAL_INVESTIGATOR · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Who to contact

Shadia Jalal, MD
[email protected]
(317) 274-5500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years at the time of informed consent
Ability to provide written informed consent and HIPAA authorization.
Eastern cooperative group (ECOG) performance status of 0 to 2
Newly diagnosed histologically or cytologically confirmed stage IV Non-Small Cell Lung Cancer (NSCLC). Patients with locally advanced NSCLC that are not candidates for definitive therapy but are candidates for trial are allowed per investigator discretion.
BMI 19 kg/m2
Patients should be enrolled prior to starting standard of care immunotherapy for the treatment of stage IV NSCLC. Patients should be on PD (L)1 inhibitor alone (i.e., with PD-L1 expression 50%) in the metastatic setting. The investigators will allow single agent pembrolizumab only as the checkpoint inhibitor.
Patients requiring palliative radiation or definitive radiation to an oligometastatic disease prior to the initiation of single agent checkpoint inhibitors are allowed once radiation has been completed and patients have recovered from toxicities.

Exclusion

Self-reported weight loss of \> 10% in the 6 weeks prior to study entry
History of symptomatic hypoglycemia or uncontrolled diabetes
Prior therapies with inhibitors of insulin growth factor I(IGF-1) such as Linsitinib or Picropodophyllin
Concurrent use of somatostatin
Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
Significant food allergies which would make the subject unable to consume the food provided.
History or current evidence of any uncontrolled medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator.
Pregnant or lactating females are not eligible.

What this trial measures

  • Feasibility of fasting mimicking diet interventionThrough study completion up to 2 years.

    Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD.

  • ComplianceThrough study completion up to 2 years.

    Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.