Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small … (NCT06671613) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
United States66 participantsStarted 2025-10-27
Plain-language summary
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Who can participate
Age range18 Years
SexALL
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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
* S…
What they're measuring
1
Feasibility of fasting mimicking diet intervention
Timeframe: Through study completion up to 2 years.
2
Compliance
Timeframe: Through study completion up to 2 years.