Dapagliflozin before surgery for stage IA lung adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early Phase I trial gives participants oral dapagliflozin once daily for 30 days prior to planned lung cancer surgery to measure safety and tolerability. Patients undergo CT‑guided tumor biopsy and serial blood and urine collection to measure tumor cell proliferation (Ki‑67), metabolic changes, and other biomarkers. Diabetic patients may be enrolled with endocrinology oversight for glucose management, and participants must meet laboratory and kidney function thresholds (including eGFR ≥30 mL/min/1.73m2). Participants are followed up between days 64 and 72 after starting treatment.

Why it matters

Who can join: the full rules

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 it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Claudio Scafoglio, MD/PhD — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Amanda R. Gonzalez
• Email: rngonzalez@mednet.ucla.edu
• Phone: 310-794-4376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.