Fasting Mimicking Diet with Immunotherapy for Lung Cancer
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Recruiting
N/AInterventional Study
Stage IV NSCLCNSCLCImmunotherapyFasting Mimicking Diet
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
66 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for patients with advanced lung cancer to see how a special diet affects cancer cells during treatment. Participants will follow a fasting-like diet while receiving standard immunotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with stage IV Non-Small Cell Lung Cancer.
My performance status is between 0 and 2.
I have a body mass index (BMI) of 19 or higher.
I will start immunotherapy for my cancer soon.
I will receive a PD-L1 inhibitor as my immunotherapy treatment.
You may not be able to join if
I have lost more than 10% of my weight in the last 6 weeks.
I have a history of severe low blood sugar or uncontrolled diabetes.
I have used certain drugs that affect insulin growth factors.
I take immunosuppressive medications like prednisone or azathioprine.
I have significant food allergies that prevent me from eating the trial food.
I have any uncontrolled medical or mental health condition.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Trial Locations
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Status
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 (NSCL…
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.
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