Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer (NCT04931017)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (17 items).
Location: Rocky Mountain Regional VA Medical Center — Aurora, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current or previous diagnosis of diabetes mellitus (type I or type II diabetes)
- Use of metformin within the past 2 years
- Use of GLP-1 agonists within 6 weeks prior to enrollment
- Glycosylated hemoglobin A1C (HbA1c) \> 8%
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin ER
- Participants currently using immunosuppressive medication, including systemic steroids (not inhalational) and episodic use of inhaled steroids are excluded from this trial due to the potential impact of these treatments on the primary trial endpoint
- Participants receiving any other investigational agents
- History of chronic alcohol use or abuse defined by any one of the following:
- Average consumption of 3 or more alcohol containing beverages daily in the past 12 months
- Consumption of 7 or more alcoholic beverages within a 24 hour period in the past 12 months
- Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado
- Roswell Park Cancer Institute — Buffalo, New York
- BC Cancer Research Centre — Vancouver, British Columbia
- University of British Columbia Hospital — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.