A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Lung Neoplasms
- Sponsor
- Mayo Clinic
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. 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.
Investigators
Dennis Wigle
M.D., P.h.D.
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Metformin
Metformin 850mg twice a day
Intervention: Metformin
Observation
Standard of Care Observation
Intervention: Placebo Comparator
Outcomes
Primary Outcomes
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
Time Frame: 2 years
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
Number of Participants With 2-year Recurrence Free Survival
Time Frame: 4 years
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Secondary Outcomes
- Number of Participants With Adverse Events as a Measure of Safety(4 years)
- Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)(4 years)