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Safety of Dapagliflozin Before Surgery for Stage IA Lung Adenocarcinoma

This study is testing the safety and side effects of a drug called dapagliflozin propanediol when given before surgery to people with stage IA lung adenocarcinoma (a type of lung cancer). Dapagliflozin is currently approved for diabetes and heart failure, but researchers are studying if it can help with this specific type of lung cancer. You might be able to join if you are at least 22 years old, have stage IA lung adenocarcinoma confirmed by a biopsy, and are planning to have surgery for your cancer. The main goal is to see how safe dapagliflozin is, and researchers will also look at its effects on the cancer cells. The study is currently unclear on its recruitment status and plans to enroll 48 participants.

Study design
This is an early phase I study, meaning it focuses on safety. It is an interventional study, and the exact phase is not specified.
What's involved
You would take dapagliflozin orally once daily for 30 days. You would also have a CT-guided lung biopsy and provide blood and urine samples throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up between days 64 and 72.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07235280

Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma

Recruiting
EARLY_PHASE1Ages 22+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~48 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed Tomography Assisted BiopsyDapagliflozin PropanediolQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to day 64-72

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

Explore related trials

Lung Adenocarcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Claudio Scafoglio, MD/PhD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
  • Jane Yanagawa, MD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Amanda R. Gonzalez
[email protected]
310-794-4376
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of adverse eventsUp 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.