Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 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. * BMI 19 kg/m2 * Patients should be enrolled prior to starting standard of care immunotherapy for the treatment of stage IV NSCLC. Patients should be on PD (L)1 inhibitor alone (i.e., with PD-L1 expression 50%) in the metastatic setting. The investigators will allow single agent pembrolizumab only as the checkpoint inhibitor. * Patients requiring palliative radiation or definitive radiation to an oligometastatic disease prior to the initiation of single agent checkpoint inhibitors are allowed once radiation has been completed and patients have recovered from toxicities. Exclusion Criteria: * 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 * Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine * Significant food allergies which would make the subject unable to consume the food provided. * History or current evidence of any uncontrolled 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. * Pregnant or lactating females are not eligible.
Study sites (4)
CA
- VA Long Beach Healthcare System, Long Beach, CA · Long Beach, CA 90822Pankaj Gupta, MD · Study contact · 562-826-8000 ext. 2243 · Pankaj.Gupta@va.govNeha Shah, PhD · Study contact · 5628268000 ext. 13284 · Neha.shah3@va.govMore trials in Long Beach
IL
- Jesse Brown VA Medical Center, Chicago, IL · Chicago, IL 60612Larry Feldman, MD · Study contact · 312-569-5385 · lawrence.feldman@va.govCindy Chan · Study contact · 3129987962 · cindy.chan2@va.govMore trials in Chicago
IN
- Richard L. Roudebush VA Medical Center, Indianapolis, IN · Indianapolis, IN 46202-2884Shadia Jalal, MD · Study contact · (317) 274-5500 · Shadia.Jalal@va.govAleksandra Radovanovich, RN · Study contact · (317) 988-3338 · aleksandra.radovanovich@va.govShadia Jalal, MD · Principal investigatorMore trials in Indianapolis
MO
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO · St Louis, MO 63106-1621Theodore Thomas, MD · Study contact · 314-652-4100 ext. 53640 · Theodore.Thomas2@va.govCarla Prost · Study contact · 3148143231 · Carla.prost@va.govMore trials in St Louis