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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fasting-mimicking diet (a special low-calorie diet designed to trick the body into a fasting state) can improve the effectiveness of immunotherapy for patients with stage IV non-small cell lung cancer. **You may be eligible if...** - You are 18 or older with newly diagnosed stage IV non-small cell lung cancer - Your tumor expresses high levels of PD-L1 (50% or more) and you qualify for single-agent pembrolizumab immunotherapy - Your performance status (ECOG) is 0, 1, or 2, meaning you can care for yourself - Your BMI is 19 or above - You have not yet started immunotherapy **You may NOT be eligible if...** - You have a specific gene mutation (like EGFR, ALK, ROS1) that would require targeted therapy instead - You have severe malnutrition or a condition that makes fasting dangerous - You have uncontrolled diabetes - You are already receiving cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

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NCT06671613


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