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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FMD
  • Regular Diet Plus FMD

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Indiana University

Collaborator

US Department of Veterans Affairs Cooperative Studies Program

Collaborator

L-Nutra Inc

Collaborator