This pilot phase II trial studies how well a fasting-mimicking diet works in increasing the effectiveness of chemo-immunotherapy in patients with non-small cell lung cancer that has spread to other places in the body (metastatic). Cancer cells use energy very differently from normal cells in the body. Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. A fasting-mimicking diet may enhance chemo-immunotherapy’s effect on cancer cells, decrease the side effects of the chemo-immunotherapy, and increase the chances of cancer responding to the chemo-immunotherapy in patients with non-small cell lung cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03700437.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the feasibility and compliance of administering a fasting-mimicking diet (FMD) in patients with advanced non-small cell lung cancer (NSCLC) receiving maintenance therapy.
SECONDARY OBJECTIVE:
I. To assess a patient’s willingness to fast for second cycle.
CORRELATIVE OBJECTIVES:
I. To assess deoxyribonucleic acid (DNA) damage via measurement of gamma-Η2ΑΧ foci in peripheral blood mononuclear cells (PBMCs) at baseline and following one cycle of FMD (day 21 or day 28).
II. To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients post FMD as compared to baseline (prior to fasting).
III. To measure the changes in immune markers prior to and after administering the FMD.
OUTLINE:
Patients consume fasting-mimicking diet on days -2, -1, 0 and 1. Patients also receive standard of care carboplatin, pemetrexed, and pembrolizumab on day 1. Patients then consume a transition diet on day 2 and regular diet on days 3-21 or 28 depending on the cycle for their standard chemotherapy treatment. Treatment continues for 21 or 28 days in the absence of disease progression or unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorShadia Ibrahim Jalal
