Stage IV NSCLCStage IV NSCLCNCT06671613
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
A study testing FMD and Regular Diet Plus FMD in people with Stage IV NSCLC and NSCLC, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV NSCLC, NSCLC, Immunotherapy
- What is being tested?
- FMD and Regular Diet Plus FMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Oct 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Larry Feldman, MD, 312-569-5385, lawrence.feldman@va.gov
Cindy Chan, 3129987962, cindy.chan2@va.gov
- Recruiting
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
Shadia Jalal, MD, (317) 274-5500, Shadia.Jalal@va.gov
Aleksandra Radovanovich, RN, (317) 988-3338, aleksandra.radovanovich@va.gov
- Recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Pankaj Gupta, MD, 562-826-8000 ext. 2243, Pankaj.Gupta@va.gov
Neha Shah, PhD, 5628268000 ext. 13284, Neha.shah3@va.gov
- Recruiting
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106-1621
Theodore Thomas, MD, 314-652-4100 ext. 53640, Theodore.Thomas2@va.gov
Carla Prost, 3148143231, Carla.prost@va.gov
About this study
Official title: Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Read the 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
- Conditions
- Stage IV NSCLC, NSCLC, Immunotherapy, Fasting Mimicking Diet
- Being tested
- FMD, Regular Diet Plus FMD
- Keywords
- PD1 inhibitors, Phase 2, Open Label, NSCLC, Fasting
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMDDietary supplement
Also called Xentigen
Plant-based diet program
Regular Diet Plus FMDCombination product
Also called Regular Diet Plus Xentigen
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6
| Study group | Role | What they receive |
|---|---|---|
| Regular Diet | Active comparator | Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6. Receives: Combination Product: Regular Diet Plus FMD |
| FMD | Experimental | Plant based diet program. Receives: Dietary Supplement: FMD; Combination Product: Regular Diet Plus FMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of fasting mimicking diet intervention
Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD.
Measured: Through study completion up to 2 years.
Compliance
Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.
Measured: Through study completion up to 2 years.
Secondary outcomes (6)
Immune Mediated Toxicities
Toxicities as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Through study completion up to 2 years.
Overall response rate (ORR)
ORR defined as complete response (CR) + partial response (PR) per RECIST 1.1 criteria.
Measured: Through study completion up to 2 years.
Disease control rate (DCR)
Defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) per RECIST 1.1
.
Measured: Through study completion up to 2 years.
Progression Free Survival (PFS)
Defined as time from day 1 of starting on study to disease progression by RECIST 1.1 or death from any cause.
Measured: Through study completion up to 2 years.
Functional Assessment of Cancer Therapy-Lung-(FACT-L)
A 36-item, questionnaire measured on a 5-point Likert scale with response options ranging from "not at all" to "very much." Total scores are summed in the range of 0 to 136. Higher scores indicate better QOL.
Measured: Through study completion up to 2 years.
European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30)
A 30-item questionnaire measured on a 4-point response option ranging from ("not at all," to "very much"), except the global QoL scale which, has a 7-point response from ("very poor" to "excellent"). Scores range from 0-100, a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Measured: Through study completion up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV NSCLCStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Indiana University, US Department of Veterans Affairs Cooperative Studies Program, L-Nutra Inc
- Responsible party
- Sponsor
- Investigators
- Shadia Jalal, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671613
- Sponsor's protocol ID
- ONCB-014-24S
- Other IDs
- 14094145/CX002843
- Acronym
- Stage IV NSCLC
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06671613
- Acronym / sponsor ID
- Stage IV NSCLC / ONCB-014-24S
- Conditions
- Stage IV NSCLC, NSCLC, Immunotherapy, Fasting Mimicking Diet
- Keywords
- PD1 inhibitors, Phase 2, Open Label, NSCLC, Fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Indiana University, US Department of Veterans Affairs Cooperative Studies Program, L-Nutra Inc
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regular Diet | Active comparator | Combination Product: Regular Diet Plus FMDPatients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6. |
| FMD | Experimental | Dietary Supplement: FMD, Combination Product: Regular Diet Plus FMDPlant based diet program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMDAlso: XentigenPlant-based diet program | Dietary supplement | FMD |
| Regular Diet Plus FMDAlso: Regular Diet Plus XentigenPatients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6 | Combination product | FMD, Regular Diet |
Primary outcome
Feasibility of fasting mimicking diet intervention
Time frame: Through study completion up to 2 years.
Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD.
Compliance
Time frame: Through study completion up to 2 years.
Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle.
6 secondary outcomes
Immune Mediated Toxicities
Time frame: Through study completion up to 2 years.
Overall response rate (ORR)
Time frame: Through study completion up to 2 years.
Disease control rate (DCR)
Time frame: Through study completion up to 2 years.
Progression Free Survival (PFS)
Time frame: Through study completion up to 2 years.
Functional Assessment of Cancer Therapy-Lung-(FACT-L)
Time frame: Through study completion up to 2 years.
European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30)
Time frame: Through study completion up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shadia Jalal, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMD and Regular Diet Plus FMD in people with Stage IV NSCLC and NSCLC, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shadia Jalal, MD ((317) 274-5500, Shadia.Jalal@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of fasting mimicking diet intervention (time frame: Through study completion up to 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.