Lung Carcinoma Clinical Trial
Official title:
Metformin for Chemoprevention of Lung Cancer in High-Risk Overweight or Obese Individuals
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.
PRIMARY OBJECTIVE: I. To evaluate the effect of metformin treatment on the expression of programmed cell death protein 1 (PD-1) on airway regulatory T cells (Tregs) in overweight and obese individuals at high risk for lung cancer. SECONDARY OBJECTIVES: I. Estimated PD-1 expression of pulmonary Tregs change in Cohort B during the wait period (26 weeks with no treatment). II. To examine the impact of metformin on circulating immune cell subsets of blood. EXPLORATORY OBJECTIVES: I. To examine the impact of metformin on cancer-related transcriptome features of airway lesions. II. To examine the impact of metformin on immune profile of pulmonary parenchyma represented by bronchoalveolar lavage (BAL). III To examine the impact of metformin on histologic progression of abnormal airway lesions. IV. To examine the impact of metformin on serum adipokines and inflammatory cytokines. OUTLINE: Participants are randomized to 1 of 2 cohorts. COHORT A: Participants receive metformin extended release (ER) orally (PO) once daily (QD) for 26 weeks in the absence of unacceptable toxicity. Participants undergo bronchoscopy biopsy and blood sample collection at screening, and week 13. COHORT B: 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. After completion of study treatment, participants are followed up at weeks 30-32 (Cohort A) and weeks 56-58 (Cohort B). ;
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