Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer

NCT06671613 | Recruiting DMC

• 2 other identifiers: ONCB-014-24S14094145/CX002843
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of fasting mimicking diet intervention

  Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD.

  Through study completion up to 2 years.

• Compliance

  Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.

  Through study completion up to 2 years.

Secondary Outcomes (6)

• Immune Mediated Toxicities

  Through study completion up to 2 years.

• Overall response rate (ORR)

  Through study completion up to 2 years.

• Disease control rate (DCR)

  Through study completion up to 2 years.

• Progression Free Survival (PFS)

  Through study completion up to 2 years.

• Functional Assessment of Cancer Therapy-Lung-(FACT-L)

  Through study completion up to 2 years.

Study Arms (2)

Regular Diet

ACTIVE COMPARATOR

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

Combination Product: Regular Diet Plus FMD

FMD

EXPERIMENTAL

Plant based diet program.

Dietary Supplement: FMD; Combination Product: Regular Diet Plus FMD

Interventions

FMD DIETARY_SUPPLEMENT

Plant-based diet program

Also known as: Xentigen

FMD

Regular Diet Plus FMD COMBINATION_PRODUCT

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

Also known as: Regular Diet Plus Xentigen

FMD; Regular Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Indiana University: collaborator
• US Department of Veterans Affairs Cooperative Studies Program: collaborator
• L-Nutra Inc: collaborator

Study Sites (4)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

RECRUITING

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

RECRUITING

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

RECRUITING

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

St Louis, Missouri, 63106-1621, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Fasting

Interventions

Diet

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shadia Jalal, MD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shadia Jalal, MD

CONTACT

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

Aleksandra Radovanovich, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Multi-center, open label, phase 2, randomized (partial crossover design) study evaluating the feasibility of FMD in stage IV NSCLC patients receiving single agent checkpoint inhibitors. Participants will be randomized 1:1 in blocks of 3. There is no blinding or stratification. Patients with high PDL1 NSCLC will be randomized to two arms: (Arm 1) 3 cycles of RD+PD1 inhibitors followed by 3 cycles of FMD+PD1 inhibitors or (Arm 2) 3 cycles of FMD+PD1 inhibitors.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)