Fasting-mimicking diet with immunotherapy for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, Phase 2-style interventional trial pairs a fasting-mimicking diet (FMD) with standard single-agent pembrolizumab in patients with newly diagnosed stage IV non-small cell lung cancer. Participants follow cycles of a low-calorie, low-protein FMD around their immunotherapy infusions while clinical outcomes, immune markers, and side effects are monitored. Outcomes for those on the FMD are compared with patients on a regular diet receiving the same immunotherapy to see whether fasting alters tumor response or toxicity. Treatment and follow-up occur at participating VA medical centers in Long Beach, Chicago, and Indianapolis.

Why it matters

Who can join: the full rules

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.

Where it's running

• VA Long Beach Healthcare System, Long Beach, CA
  Long Beach, California, United States Recruiting
• Jesse Brown VA Medical Center, Chicago, IL
  Chicago, Illinois, United States Recruiting
• Richard L. Roudebush VA Medical Center, Indianapolis, IN
  Indianapolis, Indiana, United States Recruiting
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Shadia Jalal, MD — Richard L. Roudebush VA Medical Center, Indianapolis, IN
• Study coordinator: Shadia Jalal, MD
• Email: Shadia.Jalal@va.gov
• Phone: (317) 274-5500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Narlumosbart plus targeted bone radiation with chemo‑immunotherapy for advanced non‑small cell lung cancer that has spread to bone

  We will test whether adding narlumosbart (a RANKL‑targeting antibody) and targeted bone radiation to standard first‑line chemo‑immunotherapy helps people with advanced non‑small cell lung cancer that has spread to bone.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06738160

• Monitoring cell-free DNA in lung cancer patients receiving immunotherapy

  This study is testing if measuring cell-free DNA in lung cancer patients receiving immunotherapy can help predict how well the treatment is working.

  Recruiting at 7 sites University Hospital, Strasbourg, France · Besançon and 7 other locations · NCT04720339

• MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

  This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07894458

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PULSAR radiotherapy plus immunotherapy for high-risk advanced liver cancer

  This study tests whether adding PULSAR radiotherapy to standard immunotherapy helps adults with high‑risk advanced liver cancer live longer without their cancer progressing.

  Recruiting Phase 2 Samsung Medical Center · Seoul · NCT07884877

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.