Recruiting
Early Phase 1

Dapagliflozin

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07235280

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

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography Assisted Biopsy

Dapagliflozin Propanediol

Questionnaire Administration

Study Details

Brief 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.

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

Study ID

NCT07235280

Start date

Dec 2, 2025

Status verified date

Oct, 2025

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Jun 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be able to provide written informed consent
  • Male or female ≥ 22 years of age at visit 1
  • Histologically confirmed stage Ia lung adenocarcinoma, with availability of biopsy tissue for Ki-67 determination
  • Planning to undergo surgery for lung adenocarcinoma
  • Willing and able to receive a research CT-guided lung biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Leukocytes ≥ 3.0 K/mm\^3
  • Absolute neutrophil count ≥ 1.5 K/mm\^3
  • Platelets ≥ 100 K/mm\^3
  • Total bilirubin ≤ 2 mg/dl
  • Aspartate aminotransferase (AST) ≤ 62 IU/L
  • Alanine aminotransferase (ALT) ≤ 70 IU/L
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
  • Diabetic status: diabetic subjects who are not currently receiving treatment will be included in the study. Diabetic subjects who are under treatment with insulin or oral anti-diabetic drugs will be enrolled under observation by endocrinologists on the team, to adjust the dose of the standard of care diabetic drugs to prevent hypoglycemia
  • Females of child-bearing potential must have a negative pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must agree to avoid pregnancy during the study and omit to abstinence from heterosexual intercourse or agree to use two methods of birth control (one highly effective method and one additional effective method) at least 4 weeks before the start of protocol therapy
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Women of child-bearing age will receive a urine pregnancy test to confirm eligibility
  • Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study
  • Current or previous treatment with SGLT2 inhibitors
  • History of other malignancies with exception of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma
  • Currently receiving any other investigational agents
  • Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, ketoacidosis, severe kidney disease (estimated glomerular filtration rate \[eGFR\] < 30 mL/min/1.73m\^2)
  • Subjects with HIV are eligible unless their cluster of differentiation 4 (CD4+) T-cell counts are < 350 cells/µL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Biospecimen Collection

Undergo collection of blood and urine samples

Computed Tomography Assisted Biopsy

Undergo CT-guided biopsy

Dapagliflozin Propanediol

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to day 64-72 ]

Central Contacts and Locations

Central contacts

Amanda R. Gonzalez

310-794-4376rngonzalez@mednet.ucla.edu

Tina Tieu

310-633-8400TinaTieu@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Amanda Gonzalez

310-794-4376rngonzalez@mednet.ucla.edu

Tina Tieu

310-633-8400TinaTieu@mednet.ucla.edu

Principal Investigator:

Claudio Scafoglio, MD/PhD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Feb 19, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-02-19.