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Lung AdenocarcinomaEarly Phase 1NCT07235280

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

A Early Phase 1 study testing Biospecimen Collection, Computed Tomography Assisted Biopsy and Dapagliflozin Propanediol in people with Lung Adenocarcinoma and Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Biospecimen Collection, Computed Tomography Assisted Biopsy and Dapagliflozin Propanediol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
2 Dec 2025to 29 Jun 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda R. Gonzalez contact

310-794-4376

rngonzalez@mednet.ucla.edu

Tina Tieu contact

310-633-8400

TinaTieu@mednet.ucla.edu

United States1 site, 1 recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Amanda Gonzalez, 310-794-4376, rngonzalez@mednet.ucla.edu

    Tina Tieu, 310-633-8400, TinaTieu@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

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

EXPLORATORY OBJECTIVES:

  1. 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.

Being tested
Biospecimen Collection, Computed Tomography Assisted Biopsy, Dapagliflozin Propanediol, Questionnaire Administration
Medical subject headings
Adenocarcinoma of Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood and urine samples

  • Computed Tomography Assisted BiopsyProcedure or surgery

    Also called Computed Tomography Biopsy, Computed Tomography-Guided Needle Biopsy, CT Assisted Biopsy, CT Guided Biopsy

    Undergo CT-guided biopsy

  • Dapagliflozin PropanediolDrug

    Also called Dapagliflozin Propylene Glycol Hydrate, Dapagliflozin S-propylene Glycol Monohydrate, Farxiga

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07235280
Study groupRoleWhat they receive
Treatment (dapagliflozin)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography Assisted Biopsy; Drug: Dapagliflozin Propanediol; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to day 64-72

Secondary outcomes (1)

  1. Tumor cell proliferation change

    Tumor cell proliferation change will be measured by percentage of Ki-67-positive cells at 3 separate timepoints: 1. pre-treatment archival tissue of standard of care diagnostic lung biopsy samples; 2. pre-treatment research computed tomography-guided lung biopsy; 3. post-treatment archival tissue from the standard of care lung tissue sample from the surgical resection. Will utilize mixed effect negative binomial regression models to compare the Ki-67 in pre- versus post-investigational study drug treatment lung biopsy samples. The outcome in these models will be the number of Ki-67 positive cells in the lung biopsy. The primary inference for the efficacy of the treatment will be the time effect in the model which will test whether the rate of Ki-67 positivity changes is due to the treatment.

    Measured: From biopsy to surgery up to day 64-72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start2 Dec 2025
  3. Primary completion29 Jun 2028 (estimated)
  4. Study completion29 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235280
Sponsor's protocol ID
25-1048
Other IDs
NCI-2025-07570
Status last verified
Nov 2026
First submitted
13 Nov 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biospecimen Collection, Computed Tomography Assisted Biopsy and Dapagliflozin Propanediol in people with Lung Adenocarcinoma and Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amanda R. Gonzalez (310-794-4376, rngonzalez@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to day 64-72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07235280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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