NCT06671613 · VA Office of Research and Development
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
(Stage IV NSCLC)
What this study is about
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
View original scientific description
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Interventions
DIETARY_SUPPLEMENT
FMD
Plant-based diet program
COMBINATION_PRODUCT
Regular Diet Plus FMD
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6
Primary outcome measures
Feasibility of fasting mimicking diet intervention
Time frame: Through 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.
Compliance
Time frame: Through study completion up to 2 years.
Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Long Beach, California
- Chicago, Illinois
- Indianapolis, Indiana
- St Louis, Missouri
Collaborators
Indiana University, US Department of Veterans Affairs Cooperative Studies Program, L-Nutra Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations