NCT07235280

Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma

An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess safety and tolerability of administering 30 days of neoadjuvant dapagliflozin propanediol (dapagliflozin) before surgery in subjects with stage Ia lung adenocarcinoma. SECONDARY OBJECTIVE: I. To measure the effects of dapagliflozin on tumor cell proliferation in lung adenocarcinoma. EXPLORATORY OBJECTIVES: I. To measure the effects of neoadjuvant dapagliflozin on biological and metabolic parameters. II. To measure the effects of neoadjuvant dapagliflozin on biomarkers. OUTLINE: Patients receive dapagliflozin orally (PO) once daily (QD) for 30 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)-guided biopsy on study and collection of blood and urine samples throughout the study. After completion of study treatment, patients are followed up between days 64 and 72.

Conditions

• Lung Adenocarcinoma
• Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and urine samples
PROCEDURE	Computed Tomography Assisted Biopsy	Undergo CT-guided biopsy
DRUG	Dapagliflozin Propanediol	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-12-02
• Primary completion: 2028-06-29
• Completion: 2029-06-29
• First posted: 2025-11-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study