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

ConditionsStage IV NSCLCNSCLCImmunotherapyFasting Mimicking Diet
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • FMD

    Dietary supplement

    Plant-based diet program

  • 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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Regular DietActive comparator 1 intervention
Group B: FMDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion up to 2 years.
2

Compliance

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

Time frame
Through study completion up to 2 years.

Secondary outcomes

1

Immune Mediated Toxicities

Toxicities as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

Time frame
Through study completion up to 2 years.
2

Overall response rate (ORR)

ORR defined as complete response (CR) + partial response (PR) per RECIST 1.1 criteria.

Time frame
Through study completion up to 2 years.
3

Disease control rate (DCR)

Defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) per RECIST 1.1 .

Time frame
Through study completion up to 2 years.
4

Progression Free Survival (PFS)

Defined as time from day 1 of starting on study to disease progression by RECIST 1.1 or death from any cause.

Time frame
Through study completion up to 2 years.

Other outcomes

Sponsors and contacts

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VA Office of Research and Development

Lead sponsor

Indiana University

Collaborator

US Department of Veterans Affairs Cooperative Studies Program

Collaborator

L-Nutra Inc

Collaborator

Source ClinicalTrials.gov
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