Actively Recruiting
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-02-19
48
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Male or female aged 22 years or older
- Histologically confirmed stage IA lung adenocarcinoma with biopsy tissue available for Ki-67 testing
- Planning to have surgery for lung adenocarcinoma
- Willing and able to undergo a research CT-guided lung biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Leukocyte count of at least 3.0 K/mm^3
- Absolute neutrophil count of at least 1.5 K/mm^3
- Platelet count of at least 100 K/mm^3
- Total bilirubin level of 2 mg/dl or less
- Aspartate aminotransferase (AST) level of 62 IU/L or less
- Alanine aminotransferase (ALT) level of 70 IU/L or less
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m^2
- Diabetic subjects not currently receiving treatment or under endocrinologist observation for dose adjustment
- Females of child-bearing potential must have a negative pregnancy test, not breastfeed, and agree to avoid pregnancy during the study
- Willingness and ability to follow scheduled visits, treatment plans, lab tests, and study procedures
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Considered unsuitable for the study by the Investigator due to cognitive impairment or risk
- Current or prior treatment with SGLT2 inhibitors
- History of other cancers unless treated and disease-free for at least 2 years, except certain skin cancers
- Currently receiving other investigational agents
- Regularly taking systemic steroids above 10 mg prednisone daily or equivalent, except occasional topical steroids
- History of allergic reactions to drugs similar to dapagliflozin
- Uncontrolled illness such as active infection, symptomatic heart failure, ketoacidosis, or severe kidney disease (eGFR less than 30 mL/min/1.73m^2)
- HIV-positive with CD4+ T-cell counts below 350 cells/µL or recent AIDS-defining infections within 12 months; concurrent effective antiretroviral therapy recommended
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
A
Amanda R. Gonzalez
CONTACT
T
Tina Tieu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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