Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT07235280
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Lung Adenocarcinoma
- Lung Cancer
- Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood and urine samples
- Computed Tomography Assisted Biopsy — PROCEDUREUndergo CT-guided biopsy
- Dapagliflozin Propanediol — DRUGGiven PO
- Questionnaire Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Dec 2, 2025
- Status verified
- Oct 2025
- Primary completion
- Jun 29, 2028
- Completion
- Jun 29, 2029
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (dapagliflozin)Patients receive dapagliflozin PO QD for 30 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT-guided biopsy on study and collection of blood and urine samples throughout the study.
Primary Outcome Measure
Incidence of adverse events [ Time Frame: Up to day 64-72 ]
Central Contacts
- Amanda R. Gonzalez310-794-4376
- Tina Tieu310-633-8400
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | Claudio Scafoglio, MD/PhD (PRINCIPAL_INVESTIGATOR) Jane Yanagawa, MD (PRINCIPAL_INVESTIGATOR) |
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