NCT07235280 · Jonsson Comprehensive Cancer Center
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
What this study 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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of blood and urine samples
PROCEDURE
Computed Tomography Assisted Biopsy
Undergo CT-guided biopsy
DRUG
Dapagliflozin Propanediol
Given PO
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Incidence of adverse events
Time frame: Up to day 64-72
Will be measured by frequency and severity of toxicities related to dapagliflozin per Common Terminology Criteria for Adverse Events version 6.0. Data will be summarized. Adverse events, severe adverse events, and adverse drug reactions will be coded by body system and Medical Dictionary for Regulatory Activities classification term. Adverse events will be tabulated and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations