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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
NA trial testing FMD in Stage IV NSCLC in 66 participants. Currently enrolling.
31 December 2029
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 66 |
| Start date | 27 October 2025 |
| Primary completion | 31 December 2029 |
| Estimated completion | 31 December 2030 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- FMD
- Regular Diet Plus FMD
Conditions studied
- Stage IV NSCLC — all drugs for Stage IV NSCLC →
- NSCLC — all drugs for NSCLC →
- Immunotherapy — all drugs for Immunotherapy →
- Fasting Mimicking Diet — all drugs for Fasting Mimicking Diet →
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):
-
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 -
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 -
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:
- PubMed search for NCT06671613
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FMD
Trials testing the same drug.
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- NCT04409847 — COVID-19 Blood Pressure Endothelium Interaction Study (OBELIX) · completed
- NCT04027478 — Can Fasting Decrease the Side Effects of Chemotherapy? · NA · unknown
- NCT04029571 — Effect and Safety of TCM-FMD in Phlegm-Dampness Type Overweight/Obesity Patients(EASTAR) · Phase 2 · completed
- NCT03454282 — Impact of Dietary Intervention on Tumor Immunity: the DigesT Trial · NA · unknown
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06671613 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 10 November 2025
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