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NCT06671613: Stage IV NSCLC

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

Recruiting now NA Last updated 10 November 2025
What this trial tests

NA trial testing FMD in Stage IV NSCLC in 66 participants. Currently enrolling.

Timeline
27 October 2025
Primary endpoint
31 December 2029
31 December 2030

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposesupportive care
Enrollment66
Start date27 October 2025
Primary completion31 December 2029
Estimated completion31 December 2030
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Stage IV NSCLC or NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Gut microbiota shapes cancer immunotherapy responses.
    Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 33× · PMID 40715107 · DOI 10.1038/s41522-025-00786-8
  2. Gut microbiome changes and cancer immunotherapy outcomes associated with dietary interventions: a systematic review of preclinical and clinical evidence.
    Somodi C, Dora D, Horváth M, Szegvari G, et al · · 2025 · cited 7× · PMID 40629403 · DOI 10.1186/s12967-025-06586-0
  3. Nutritional strategies in supporting immune checkpoint inhibitor, PI3K inhibitor, and tyrosine kinase inhibitor cancer therapies.
    Fuller-Shavel N, Davies EJ, Peleg Hasson S. · · 2025 · PMID 41425618 · DOI 10.3389/fnut.2025.1670598

Verify or expand the search:

Other trials of FMD

Trials testing the same drug.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06671613.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing