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

Conditions

• Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

30 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Biopsy — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bronchoscopy — PROCEDURE
  Undergo bronchoscopy
• Extended Release Metformin Hydrochloride — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Sep 9, 2022

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

50 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Experimental: Cohort A - Former Smokers (metformin ER)
  Participants receive metformin ER PO QD for 26 weeks in the absence of unacceptable toxicity. Participants undergo bronchoscopy biopsy and blood sample collection at screening, and week 13.
• Active Comparator: Cohort B - Former Smokers (metformin ER with waiting period)
  Participants receive no intervention for 26 weeks, then cross-over to Cohort A. Participants undergo bronchoscopy biopsy and blood sample collection at screening, at week 26, and at 13 weeks after cross-over to Cohort A.

Primary Outcome Measure

PD-1 expression of pulmonary regulatory T cells (Tregs) before and after metformin extended release (ER) treatment [ Time Frame: Pre- to post-treatment ]

Locations (2)

Find similar trials in Aurora, CO

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