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

NCT07235280 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 25-1048NCI-2025-07570
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  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.

  Up to day 64-72

Secondary Outcomes (1)

• Tumor cell proliferation change

  From biopsy to surgery up to day 64-72

Study Arms (1)

Treatment (dapagliflozin)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography Assisted Biopsy; Drug: Dapagliflozin Propanediol; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and urine samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (dapagliflozin)

Computed Tomography Assisted Biopsy PROCEDURE

Undergo CT-guided biopsy

Also known as: Computed Tomography Biopsy, Computed Tomography-Guided Needle Biopsy, CT Assisted Biopsy, CT Guided Biopsy

Treatment (dapagliflozin)

Dapagliflozin Propanediol DRUG

Given PO

Also known as: Dapagliflozin Propylene Glycol Hydrate, Dapagliflozin S-propylene Glycol Monohydrate, Farxiga

Treatment (dapagliflozin)

Questionnaire Administration OTHER

Ancillary studies

Treatment (dapagliflozin)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung; Lung Neoplasms

Interventions

Specimen Handling; dapagliflozin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Claudio Scafoglio, MD/PhD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Jane Yanagawa, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda R. Gonzalez

CONTACT

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

Tina Tieu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): June 29, 2028
• Study Completion (Estimated): June 29, 2029
• Last Updated: February 19, 2026

Record last verified: 2025-10

Locations

US (1)