Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
NCT ID: NCT06671613
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2025-10-27
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Regular Diet
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6.
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
FMD
Plant based diet program.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
US Department of Veterans Affairs Cooperative Studies Program
NETWORK
L-Nutra Inc
INDUSTRY
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Shadia Jalal, MD
Role: PRINCIPAL_INVESTIGATOR
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Pankaj Gupta, MD
Role: primary
Neha Shah, PhD
Role: backup
Larry Feldman, MD
Role: primary
Cindy Chan
Role: backup
Shadia Jalal, MD
Role: primary
Aleksandra Radovanovich, RN
Role: backup
Theodore Thomas, MD
Role: primary
Carla Prost
Role: backup
Other Identifiers
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14094145/CX002843
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ONCB-014-24S
Identifier Type: -
Identifier Source: org_study_id