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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a special diet that mimics fasting might work alongside immunotherapy for patients with stage IV non-small cell lung cancer (NSCLC). The main goal is to see if this fasting-mimicking diet can help improve the effects of standard cancer treatments while you receive ongoing care. The trial is currently not recruiting participants, but it aims to include adults aged 18 and older who have just been diagnosed with stage IV NSCLC and are beginning immunotherapy treatment.

To be eligible for this study, participants must be in reasonably good health and have a performance status that allows them to carry out daily activities. They should not have lost a significant amount of weight recently or have certain medical conditions that could complicate the trial, such as uncontrolled diabetes or severe food allergies. Participants will be guided through the diet and treatment process, and they can expect support from the research team throughout their participation. This trial could provide valuable insights into new ways to enhance cancer treatments for patients facing this challenging diagnosis.

Gender

ALL

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.