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Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer

NCT04931017 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-07

No results posted yet for this study

Summary

This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients' immune system learn ("reprogram") to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development.

Conditions

  • Lung Carcinoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bronchoscopy

Undergo bronchoscopy

DRUG

Extended Release Metformin Hydrochloride

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Saikrishna S Yendamuri · Roswell Park University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-09
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04931017 on ClinicalTrials.gov