SGLT2 Inhibitors and Survival in Lung Cancer Patients With Diabetes

November 26, 2025 updated by: Liang Zhao, Shanghai Chest Hospital

The Impact of SGLT2i on the Outcome of Advanced Lung Cancer in Patients With Diabetes

The goal of this clinical trial

The goal of this clinical trial is to evaluate whether SGLT2 inhibitor drugs can extend overall survival or delay the progression of the tumor in patients with both advanced lung cancer and diabetes. It will also check if these drugs are safe for these patients. The main questions it aims to answer are:

  • Does adding an SGLT2 inhibitor to standard cancer treatment improve survival?
  • Does it cause more or fewer cardiovascular toxicity?
  • What side effects do participants experience? Researchers will compare a group taking an SGLT2 inhibitor to a group not taking SGLT2 inhibitor to see if the drug works.

Participants will:

  • Be adults diagnosed with advanced lung cancer and type 2 diabetes.
  • Take either the SGLT2 inhibitor pill or other hypoglycemic drugs once a day alongside their cancer treatment.
  • Undergo regular clinical visits for monitoring, laboratory tests, and imaging studies

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Lung cancer patients receiving standard anti-tumor treatment; type 2 diabetes; patients with a score of 0-2 assessed by Eastern Cooperative Oncology Group's performance status; the patients agreed to participate in this study.

Exclusion Criteria:

  • Severe abnormalities in liver, kidney or heart functions; expected lifespan less than 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
On the basis of standard cancer treatment, take dapagliflozin for at least three months, once a day, 10 mg each time.
Drug: SGLT-2 inhibitor
SGLT2 inhibitors used for patients with lung cancer and diabetes
Sham Comparator: control group
Based on the standard treatment for tumors, for the treatment of diabetes, no dapagliflozin has been taken.
Other: Sham (No Treatment)
SGLT2 inhibitors are not used for patients with lung cancer and diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with death
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with new-onset atrial fibrillation/flutter, acute coronary syndrome, myocarditis, massive pericardial effusion, heart failure and third-degree atrioventricular block.
Time Frame: From enrollment to the end of treatment at 12 months
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 7, 2025

Primary Completion (Estimated)

October 7, 2026

Study Completion (Estimated)

November 7, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLC-DO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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