NCT06671613 Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
| NCT ID | NCT06671613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Stage IV NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-10-27 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Eligibility 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.
Contact & Investigator
Shadia Jalal, MD
PRINCIPAL INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Frequently Asked Questions
Who can join the NCT06671613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage IV NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671613 currently recruiting?
Yes, NCT06671613 is actively recruiting participants. Contact the research team at Shadia.Jalal@va.gov for enrollment information.
Where is the NCT06671613 trial being conducted?
This trial is being conducted at Long Beach, United States, Chicago, United States, Indianapolis, United States, St Louis, United States.
Who is sponsoring the NCT06671613 clinical trial?
NCT06671613 is sponsored by VA Office of Research and Development. The principal investigator is Shadia Jalal, MD at Richard L. Roudebush VA Medical Center, Indianapolis, IN. The trial plans to enroll 66 participants.