RecruitingEarly Phase 1NCT07235280

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

Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

48 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer 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

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diabetes medication called dapagliflozin (commonly used for Type 2 diabetes and heart/kidney conditions) is safe to take before surgery in people with very early-stage lung cancer, and whether it might slow the tumor's growth before it is removed. **You may be eligible if...** - You are 22 or older - You have confirmed Stage IA lung adenocarcinoma (a very early stage of lung cancer) - You are scheduled for surgery to remove the tumor - You are willing to have a research-related biopsy before surgery - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have advanced lung cancer (Stage IB or higher) - You have very poor kidney function - You have Type 1 diabetes - You have had serious urinary tract infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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