NCT06671613Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 31 Oct 2024
- Start date
- 27 Oct 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Lung cancer
- NCT number
- NCT06671613
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 27 Oct 2025 to the primary completion date, 31 Dec 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Self-reported weight loss of \> 10% in the 6 weeks prior to study entry
- 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
Other illness
- History of symptomatic hypoglycemia or uncontrolled diabetes
- 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.
Other
- Pregnant or lactating females are not eligible.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Richard L. Roudebush VA Medical Center, Indianapolis, IN Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| VA Long Beach Healthcare System, Long Beach, CA Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.