Clinical trial · Interventional
Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer
NCT03700437CI-TRIAL-00058463completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting-Mimicking Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fasting-Mimicking Diet (FMD)
- description
- Participants randomized to the intervention arm (FMD) will be provided with Chemolieve®, a plant-based FMD that provides \~300 calories/fasting day and includes all the food to be consumed during the dietary intervention including supplements Subjects will start the diet 3 days prior to chemo-immunotherapy and continue on the first day of chemo-immunotherapy for the first 4 cycles of therapy.
- interventionNames
- Other: Fasting-Mimicking Diet
Primary outcomes (1)
- measure
- Proportion of the patients who can finish the FMD without serious adverse events
- timeFrame
- Between screening/baseline (28 to 4 days before Cycle 1 Day 1) and Cycle 1 Day 21 or 28 (Cylces last 21 or 28 days, based on treatment)
- description
- To assess feasibility, compliance will be measured by a daily log
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Eastern cooperative group (ECOG) performance status of 0 to 2 4. Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) and have advanced disease. 5. BMI ≥ 19 6. Patients should be on maintenance therapy for advanced NSCLC as defined as treatment with single agent immunotherapy, single agent chemotherapy plus immunotherapy or single agent molecularly targeted therapy for a minimum of 2 months prior to study entry 7. If a patient is on a treatment that lowers their ANC, their ANC has to be ≥ 1500 on the first day of fasting Exclusion Criteria: 1. Self-reported weight loss of \> 10% in the 6 weeks prior to study entry 2. History of diabetes mellitus or patients with a known recent elevated A1c \> 6 3. History of symptomatic hypoglycemia 4. Prior therapies with inhibitors of IGF-1 such as 1. Linsitinib 2. Picropodophyllin 5. Concurrent use of somatostatin 6. Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine 7. Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided 8. History or current evidence of any 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. 9. Pregnant or lactating females are not eligible.
References
Publications (1)
- DERIVEDGhaddar F, Ahmed S, Kirsch B, Jennewein L, Uhrich MM, Althouse SK, Longo V, Jalal S. Brief Report: A Pilot Study Evaluating the Feasibility, Safety, and Compliance With a Fasting-Mimicking Diet in Patients With Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2026 May;27(4):24-28. doi: 10.1016/j.cllc.2026.03.017. Epub 2026 Apr 1. PMID 42060951