NCT07272057

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
6mo left

Started Dec 2025

Shorter than P25 for not_applicable lung-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Dec 2025Nov 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

December 7, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2026

Last Updated

December 9, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

November 18, 2025

Last Update Submit

November 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with death

    From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

  • Number of Participants with new-onset atrial fibrillation/flutter, acute coronary syndrome, myocarditis, massive pericardial effusion, heart failure and third-degree atrioventricular block.

    From enrollment to the end of treatment at 12 months

Study Arms (2)

treatment group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

Based on the standard treatment for tumors, for the treatment of diabetes, no dapagliflozin has been taken.

Other: Sham (No Treatment)

Interventions

SGLT2 inhibitors are not used for patients with lung cancer and diabetes

control group

SGLT2 inhibitors used for patients with lung cancer and diabetes

treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Sodium-Glucose Transporter 2 Inhibitorssalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 9, 2025

Study Start

December 7, 2025

Primary Completion (Estimated)

October 7, 2026

Study Completion (Estimated)

November 7, 2026

Last Updated

December 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share