SGLT2 Inhibitors and Survival in Lung Cancer Patients Wit... | NCT07272057

Studies
SGLT2 Inhibitors and Survival in Lung Cancer Patients With Diabetes

NCT07272057

Sponsor

Shanghai Chest Hospital

Status

Not yet recruiting

Last Update Posted

Dec 9, 2025Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

SGLT-2 inhibitor
Sham (No Treatment)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 7, 2025Estimated

Primary Completion Date

Oct 7, 2026Estimated

Completion Date

Nov 7, 2026Estimated

First Submitted Date

Nov 18, 2025

First Submission Date that Met QC Criteria

Nov 26, 2025

First Posted Date

Dec 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SGLT-2 inhibitor	Drug	SGLT2 inhibitors used for patients with lung cancer and diabetes	treatment group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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.		From enrollment to the end of treatment at 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jindong Chen	Contact	+862122200000		cjdxk2016@163.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors
C005703	salicylhydroxamic acid

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

Browse Leaves

Not provided

Browse Branches

Not provided