Dapagliflozin for Lung Cancer

Overseen By Tina Tieu

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: SGLT2 inhibitors, Systemic steroids

Disqualifiers: Pregnancy, Other malignancies, Severe kidney disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 64

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and side effects of dapagliflozin, a medication typically used for diabetes and heart failure, when administered before surgery to patients with early-stage lung cancer (specifically stage IA lung adenocarcinoma). Researchers aim to determine if this drug can enhance surgical effectiveness by targeting a specific protein elevated in this cancer stage. Individuals diagnosed with stage IA lung adenocarcinoma and planning surgery may be suitable candidates for this trial. Participants will take dapagliflozin daily for 30 days and undergo tests, such as a biopsy and blood samples, to monitor progress. As an Early Phase 1 trial, this research seeks to understand how dapagliflozin functions in people with this type of cancer, offering a unique opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are diabetic and on insulin or oral anti-diabetic drugs, your dose may be adjusted by the study's endocrinologists to prevent low blood sugar. If you are on systemic steroids or other investigational drugs, you may not be eligible to participate.

Is there any evidence suggesting that dapagliflozin is likely to be safe for humans?

Research has shown that dapagliflozin, a drug typically used for diabetes and heart failure, might also benefit lung cancer patients. Studies suggest that drugs like dapagliflozin are linked to a lower risk of developing lung cancer, which addresses safety concerns.

The FDA has already approved dapagliflozin for other health issues, indicating its general safety for those uses. Although the researchers are currently testing it for lung cancer, this background offers some reassurance about its safety. However, as this is an early phase trial, the full safety profile for lung cancer patients is still being explored. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and radiation treatments for lung cancer, dapagliflozin offers a fresh approach by targeting glucose transport in cancer cells. Originally used to manage diabetes, dapagliflozin works by inhibiting a protein responsible for glucose reabsorption in the kidneys, which could potentially starve cancer cells of the glucose they need to grow. Researchers are excited because this unique mechanism might slow down or stop tumor growth without the harsh side effects associated with traditional therapies. Additionally, as an oral medication, dapagliflozin offers a more convenient option compared to intravenous treatments, potentially improving the quality of life for patients.

What evidence suggests that dapagliflozin might be an effective treatment for stage IA lung adenocarcinoma?

Research has shown that dapagliflozin, an SGLT2 inhibitor, might reduce the risk of lung cancer. Some studies found that people taking SGLT2 inhibitors, such as dapagliflozin, had a lower chance of developing lung cancer compared to those using other treatments. Specifically, one study found a 13% lower risk of lung cancer for those on SGLT2 inhibitors. Additionally, lab experiments have shown that dapagliflozin can slow the growth of certain cancer cells. This trial will evaluate dapagliflozin's potential to improve outcomes for lung cancer patients, particularly those with early-stage tumors that have high levels of SGLT2 proteins. ^{1 6 7 8 9}

Who Is on the Research Team?

Claudio Scafoglio, MD/PhD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Jane Yanagawa, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with early-stage lung adenocarcinoma (Stage IA). Participants should be candidates for surgery, and they must not have received any prior treatments for their cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health standards.

Inclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant and agree to use two forms of birth control.

I am willing and able to follow the study's schedule and procedures.

I am 22 years old or older.

Exclusion Criteria

I am taking more than 10 mg of prednisone or its equivalent daily.

I do not have any severe illnesses like heart failure, serious infections, or severe kidney disease.

I have HIV but my CD4+ T-cell count is above 350, and I haven't had an AIDS-related infection in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dapagliflozin orally once daily for 30 days. Patients also undergo CT-guided biopsy and collection of blood and urine samples.

4 weeks

Daily oral administration, multiple visits for biopsy and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and tumor cell proliferation changes.

8-12 days

Follow-up visits between days 64 and 72

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin

Trial Overview The trial is testing the safety of Dapagliflozin, a diabetes and heart failure medication, given before surgery to see if it can improve outcomes in lung cancer treatment. The study involves biospecimen collection, CT-assisted biopsy, and questionnaires.

How Is the Trial Designed?

Group I: Treatment (dapagliflozin) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12330067/

Comparative risk of cancer associated with SGLT inhibitors ... Subgroup analyses revealed significantly lower risks for liver (RR = 0.76), lung (RR = 0.87), and prostate (RR = 0.75) cancers with SGLT2i.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12186366/

Unveiling the anticancer potential of SGLT-2 inhibitors The study suggested that dapagliflozin may increase the overall risk of malignant tumors compared to other oral hypoglycemic agents, whereas ...

3. mdpi.com mdpi.com/2072-6694/17/3/466?type=check_update&version=2

Exploring the Role of SGLT2 Inhibitors in Cancer The addition of 2 months of oral dapagliflozin (10 mg/day) to GnP was well-tolerated. Of the 12 evaluable patients, 2 had a partial response (PR), 9 had stable ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf

CENTER FOR DRUG EVALUATION AND RESEARCH FARXIGA on CV outcomes (the DECLARE trial) support the conclusion that FARXIGA is also likely to be effective in patients with less advanced CKD ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0014299924006927

Dapagliflozin suppressed gastric cancer growth via ... We found that Dapagliflozin (a SGLT2 inhibitor) could suppress gastric cancer cell proliferation and migration in vitro and tumor growth in vivo.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07235280

Testing the Safety of Dapagliflozin Prior to Surgery for ... This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10070339/

Sodium-glucose cotransporter 2 (SGLT2) inhibitors and ... Our large SEER-Medicare linked data study indicates that SGLT2 inhibitors use was associated with improved overall survival of NSCLC patients with pre-existing ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822723000967

Sodium-glucose cotransporter-2 inhibitors and cancer ... Conclusions. SGLT2 inhibitors are not associated with an increased risk of cancer outcomes, providing reassuring data regarding previous safety concerns.

9. jacc.org jacc.org/doi/10.1016/j.jaccao.2024.08.001

SGLT2i and Primary Prevention of Cancer Therapy ... SGLT2i administration was associated with a significantly decreased risk of developing CTRCD in patients with T2DM and cancer.