Recruiting

Fasting with Treatment

Sponsor:

VA Office of Research and Development

Code:

NCT06671613

Conditions

Stage IV NSCLC

NSCLC

Immunotherapy

Fasting Mimicking Diet

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FMD

Regular Diet Plus FMD

Study Details

Brief summary:

The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Conditions

Stage IV NSCLC

NSCLC

Immunotherapy

Fasting Mimicking Diet

Study ID

NCT06671613

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Regular Diet

Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6.

experimental: FMD

Plant based diet program.

Interventions

FMD

Plant-based diet program

Regular 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

Primary outcome measure

  • Feasibility of fasting mimicking diet intervention [ Time Frame: Through study completion up to 2 years. ]
  • Compliance [ Time Frame: Through study completion up to 2 years. ]

Central Contacts and Locations

Central contacts

Shadia Jalal, MD

(317) 274-5500Shadia.Jalal@va.gov

Aleksandra Radovanovich, RN

(317) 988-3338aleksandra.radovanovich@va.gov

Locations

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Pankaj Gupta, MD

562-826-8000Pankaj.Gupta@va.gov

Neha Shah, PhD

5628268000Neha.shah3@va.gov

Jesse Brown VA Medical Center, Chicago, IL

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Larry Feldman, MD

312-569-5385lawrence.feldman@va.gov

Cindy Chan

3129987962cindy.chan2@va.gov

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Recruiting

Indianapolis, Indiana, United States, 46202-2884

Contacts

Shadia Jalal, MD

(317) 274-5500Shadia.Jalal@va.gov

Aleksandra Radovanovich, RN

(317) 988-3338aleksandra.radovanovich@va.gov

Principal Investigator:

Shadia Jalal, MD

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

Recruiting

St Louis, Missouri, United States, 63106-1621

Contacts

Theodore Thomas, MD

314-652-4100Theodore.Thomas2@va.gov

Carla Prost

3148143231Carla.prost@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • PD1 inhibitors
  • Phase 2
  • Open Label
  • NSCLC
  • Fasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-10.