RecruitingNot ApplicableNCT06671613
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
Sponsor
VA Office of Research and Development
Enrollment
66 participants
Start Date
Oct 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria8
- 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.
Interventions
DIETARY_SUPPLEMENTFMD
Plant-based diet program
COMBINATION_PRODUCTRegular 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
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06671613
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