This trial is active, not recruiting.

Conditions lung neoplasms, carcinoma, non-small-cell lung
Treatments metformin, placebo comparator
Phase phase 2
Sponsor Mayo Clinic
Collaborator Alliance for Clinical Trials in Oncology
Start date October 2012
End date January 2017
Trial size 100 participants
Trial identifier NCT01717482, 12-006865


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Metformin 850mg BID
metformin Glucophage
(Placebo Comparator)
Standard of Care Observation
placebo comparator
Standard of Care Observation

Primary Outcomes

Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
time frame: 2 years
Number of Participants with 2-year Recurrence Free Survival
time frame: 4 years

Secondary Outcomes

Measure Metformin Sensitivity in iPS (Induced Pluripotent Stem Cells)
time frame: 4 years
Number of Participants with Adverse Events as a Measure of Safety
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (must be proven SCC at the time of surgery) - 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 - Subject must start Metformin within 90 days 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 - Existing untreated or prior cancer <5 years from diagnosis - Received neo-adjuvant platinum-based chemotherapy or targeted therapy - Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection

Additional Information

Official title A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Principal investigator Dennis Wigle, MD, PhD
Description Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, MN. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.