RecruitingNot applicableNCT06671613

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

The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Checked against the public recordLast updated Nov 10, 2025 · Source: ClinicalTrials.gov

StatusRecruiting
PhaseNot applicable
U.S. locations4
SponsorVA Office of Research and Development
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
VA Office of Research and Development
Interventions being studied
Dietary Supplement: FMD; Combination Product: Regular Diet Plus FMD
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • VA Long Beach Healthcare System, Long Beach, CALong Beach, California
  • Jesse Brown VA Medical Center, Chicago, ILChicago, Illinois
  • Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolis, Indiana
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MOSt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 10, 2025. Always confirm current availability with the study team.

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