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Could fasting boost immunotherapy? new trial tests diet combo for lung cancer

NCT ID NCT06671613

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special low-calorie, plant-based diet that mimics fasting can help patients with stage IV non-small cell lung cancer respond better to maintenance immunotherapy. Sixty-six participants will follow the diet for three cycles while continuing their regular treatment. The main goal is to see if patients can safely complete the diet, with secondary goals of measuring tumor response and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fasting-mimicking diet (Xentigen plant-based diet program)
What this could lead to
If it works, this could point toward a simple dietary strategy to boost the effectiveness of immunotherapy for advanced lung cancer.
What could go wrong
This is a small, early feasibility study (66 people) with no control group. It only tests if patients can stick to the diet, not yet if it improves outcomes. The diet may cause side effects or be hard to follow.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jesse Brown VA Medical Center, Chicago, IL

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    RECRUITING

    Indianapolis, Indiana, 46202-2884, United States

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

    RECRUITING

    St Louis, Missouri, 63106-1621, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

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