An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma
This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma. Dapagliflozin is approved by the Food and Drug Administration (FDA) for the treatment of diabetes and heart failure. It is an SGLT2 inhibitor. Stage I lung adenocarcinomas express significantly higher levels of the SGLT2 protein than other stages, and research suggests that SGLT2 inhibition improves lung cancer outcomes in patients with diabetes. In this study, dapagliflozin is being used off-label, which means it is being used for a condition that it was not originally approved for by the FDA. The investigational study drug is a neoadjuvant treatment, meaning the drug is given before surgery to try and help make the surgery more effective.
• Must be able to provide written informed consent
• Male or female ≥ 22 years of age at visit 1
• Histologically confirmed stage Ia lung adenocarcinoma, with availability of biopsy tissue for Ki-67 determination
• Planning to undergo surgery for lung adenocarcinoma
• Willing and able to receive a research CT-guided lung biopsy
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Leukocytes ≥ 3.0 K/mm\^3
• Absolute neutrophil count ≥ 1.5 K/mm\^3
• Platelets ≥ 100 K/mm\^3
• Total bilirubin ≤ 2 mg/dl
• Aspartate aminotransferase (AST) ≤ 62 IU/L
• Alanine aminotransferase (ALT) ≤ 70 IU/L
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
• Diabetic status: diabetic subjects who are not currently receiving treatment will be included in the study. Diabetic subjects who are under treatment with insulin or oral anti-diabetic drugs will be enrolled under observation by endocrinologists on the team, to adjust the dose of the standard of care diabetic drugs to prevent hypoglycemia
• Females of child-bearing potential must have a negative pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must agree to avoid pregnancy during the study and omit to abstinence from heterosexual intercourse or agree to use two methods of birth control (one highly effective method and one additional effective method) at least 4 weeks before the start of protocol therapy
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures