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NCT07235280RecruitingEarly phase 1

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

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
48 (estimated)
First submitted
13 Nov 2025
Start date
2 Dec 2025
Primary completion date
29 Jun 2028
Lead sponsor
Jonsson Comprehensive Cancer Center
Diseases
Lung cancer
NCT number
NCT07235280

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 48
  • From 2 Dec 2025 to the primary completion date, 29 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or previous treatment with SGLT2 inhibitors
  • 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

Other illness

  • 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
  • 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
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin

Lab values

  • 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

Age

  • 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

Who the study is looking for

  • 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

Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCLA / Jonsson Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.