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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    II What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 12-006865
  • NCT ID:

  • Sponsor Protocol Number:


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dennis Wigle, M.D., Ph.D.

Open for enrollment

Karlyn Pierson M.A.N., R.N.