Fasting-mimicking diet with immunotherapy for advanced non-small cell lung cancer
Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
This trial will test whether following a fasting-mimicking diet while receiving pembrolizumab helps people with advanced non-small cell lung cancer respond better and have fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | pembrolizumab, Linsitinib, immunotherapy, radiation, prednisone |
| Locations | 4 sites (Long Beach, California and 3 other locations) |
| Trial ID | NCT06671613 on ClinicalTrials.gov |
What this trial studies
This open-label, Phase 2-style interventional trial pairs a fasting-mimicking diet (FMD) with standard single-agent pembrolizumab in patients with newly diagnosed stage IV non-small cell lung cancer. Participants follow cycles of a low-calorie, low-protein FMD around their immunotherapy infusions while clinical outcomes, immune markers, and side effects are monitored. Outcomes for those on the FMD are compared with patients on a regular diet receiving the same immunotherapy to see whether fasting alters tumor response or toxicity. Treatment and follow-up occur at participating VA medical centers in Long Beach, Chicago, and Indianapolis.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed stage IV NSCLC who are scheduled to start single-agent pembrolizumab, have ECOG performance status 0–2, and a BMI of at least 19 kg/m2.
Not a fit: Patients who have already started immunotherapy, require combination chemotherapy, have low BMI or poor performance status, or cannot safely fast may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, combining a fasting-mimicking diet with pembrolizumab could increase tumor response rates and reduce immunotherapy side effects.
How similar studies have performed: Early laboratory work and small human studies combining fasting or fasting-mimicking diets with cancer therapies have shown promising signals, but evidence specifically with immunotherapy in NSCLC is limited and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Long Beach, California and 3 other locations
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (Recruiting)
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States (Recruiting)
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (Recruiting)
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Shadia Jalal, MD — Richard L. Roudebush VA Medical Center, Indianapolis, IN
- Study coordinator: Shadia Jalal, MD
- Email: Shadia.Jalal@va.gov
- Phone: (317) 274-5500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.