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

NCT ID: NCT07235280

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2029-12-30

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess safety and tolerability of administering 30 days of neoadjuvant dapagliflozin propanediol (dapagliflozin) before surgery in subjects with stage Ia lung adenocarcinoma.

SECONDARY OBJECTIVE:

I. To measure the effects of dapagliflozin on tumor cell proliferation in lung adenocarcinoma.

EXPLORATORY OBJECTIVES:

I. To measure the effects of neoadjuvant dapagliflozin on biological and metabolic parameters.

II. To measure the effects of neoadjuvant dapagliflozin on biomarkers.

OUTLINE:

Patients receive dapagliflozin orally (PO) once daily (QD) for 30 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT)-guided biopsy on study and collection of blood and urine samples throughout the study.

After completion of study treatment, patients are followed up between days 64 and 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood and urine samples

Computed Tomography Assisted Biopsy

Intervention Type: PROCEDURE

Undergo CT-guided biopsy

Dapagliflozin Propanediol

Intervention Type: DRUG

Given PO

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Biospecimen Collection

Undergo collection of blood and urine samples

Intervention Type: PROCEDURE

Computed Tomography Assisted Biopsy

Undergo CT-guided biopsy

Intervention Type: PROCEDURE

Dapagliflozin Propanediol

Given PO

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection; Computed Tomography Biopsy; Computed Tomography-Guided Needle Biopsy; CT Assisted Biopsy; CT Guided Biopsy; Dapagliflozin Propylene Glycol Hydrate; Dapagliflozin S-propylene Glycol Monohydrate; Farxiga

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Scafoglio, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Jane Yanagawa, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Amanda R. Gonzalez

Role: CONTACT

rngonzalez@mednet.ucla.edu

310-794-4376

Tina Tieu

Role: CONTACT

TinaTieu@mednet.ucla.edu

310-633-8400

Facility Contacts

Amanda Gonzalez

Role: primary

rngonzalez@mednet.ucla.edu

310-794-4376

Tina Tieu

Role: backup

TinaTieu@mednet.ucla.edu

310-633-8400

Other Identifiers

NCI-2025-07570

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-1048

Identifier Type: -

Identifier Source: org_study_id