A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Patients will be identified and enrolled from Thoracic Surgical Clinics. A preoperative bronchoscopy will be performed to obtain systematic bronchial biopsies from defined proximal airway sites. Patients will then undergo surgical resection and tumor tissue and normal lung specimens collected. For patients with bronchial dysplasia postoperatively, starting less than 6 months from the time of surgery, patients will be randomized to receive either 850 mg po BID of metformin or observation. Metformin dosing will include a 4 week ramp up of 850 mg po daily prior to starting the BID dose. Adjuvant platinum-based chemotherapy will be applied at the discretion of treating physicians. Patients found to have bronchial dysplasia at the time of bronchoscopy will undergo follow up bronchoscopy and tissue sampling at 6 months follow up.

Who is eligible to participate?

Inclusion Criteria - Suspected or biopsy proven Stage IB-IIIA NSCLC-squamous - Coincident bronchial dysplasia and/or carcinoma in situ from at least 1 non-resected location - Medically fit for surgical resection (based on surgeon assessment) - Current or prior smoker - Age > 18 years old - Both Male and Female - Willing and able to consent to study, undergo study interventions, and take study drug - ECOG performance status 0, 1, 2 - Must start Metformin within 6 months of surgery Exclusion Criteria - Currently taking metformin or other diabetic drugs - Current or previous congestive heart failure, renal failure or liver failure - Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater

Last updated:

2/20/2014

NCT ID:

NCT01717482

IRB Number:

12-006865