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Clinical Trials (PDQ®)

Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionActiveOver 18Other12-006865
NCT01717482

Trial Description

Summary

The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Alliance for Clinical Trials in Oncology

Dennis WiglePrincipal Investigator

Karlyn E Pierson, RNPh: 507-538-1960
  Email: pierson.karlyn@mayo.edu

Trial Sites

U.S.A.
Minnesota
  Rochester
 Mayo Clinic Cancer Center

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01717482
ClinicalTrials.gov processed this data on September 10, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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