Clinical trial NCT06671613: Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Official title: Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stage IV NSCLC
NSCLC
Immunotherapy
Fasting Mimicking Diet
Keywords: PD1 inhibitors
Phase 2
Open Label
NSCLC
Fasting
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Indiana University
name: US Department of Veterans Affairs Cooperative Studies Program
name: L-Nutra Inc
First posted: 2024-11-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multi-center, open label, phase 2, randomized (partial crossover design) study evaluating the feasibility of FMD in stage IV NSCLC patients receiving single agent checkpoint inhibitors. Participants will be randomized 1:1 in blocks of 3. There is no blinding or stratification. Patients with high PDL1 NSCLC will be randomized to two arms: (Arm 1) 3 cycles of RD+PD1 inhibitors followed by 3 cycles of FMD+PD1 inhibitors or (Arm 2) 3 cycles of FMD+PD1 inhibitors.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.

Detailed description: Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. Because of this, researchers would like to study how fasting may help immunotherapy target cancer cells. Initial studies suggest that fasting may decrease the side effects of immunotherapy and increase the chances of your cancer responding to the immunotherapy. Patient populations will have non-small cell lung cancer in which pembrolizumab have been recommended to treat the cancer as part of standard care

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.

Primary outcomes:
measure: Feasibility of fasting mimicking diet intervention
timeFrame: Through study completion up to 2 years.
measure: Compliance
timeFrame: Through study completion up to 2 years.
Secondary outcomes:
measure: Immune Mediated Toxicities
timeFrame: Through study completion up to 2 years.
measure: Overall response rate (ORR)
timeFrame: Through study completion up to 2 years.
measure: Disease control rate (DCR)
timeFrame: Through study completion up to 2 years.
measure: Progression Free Survival (PFS)
timeFrame: Through study completion up to 2 years.
measure: Functional Assessment of Cancer Therapy-Lung-(FACT-L)
timeFrame: Through study completion up to 2 years.
measure: European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30)
timeFrame: Through study completion up to 2 years.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Shadia Jalal, MD
role: PRINCIPAL_INVESTIGATOR
References: