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 — PROCEDURE
    Undergo collection of blood and urine samples
  • Computed Tomography Assisted Biopsy — PROCEDURE
    Undergo CT-guided biopsy
  • Dapagliflozin Propanediol — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary 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

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Amanda Gonzalez
310-794-4376
Tina Tieu
310-633-8400
Claudio Scafoglio, MD/PhD (PRINCIPAL_INVESTIGATOR)
Jane Yanagawa, MD (PRINCIPAL_INVESTIGATOR)

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