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

Phase 2TerminatedNCT01717482

Mayo Clinic6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Interventions

MetforminDRUG

Placebo ComparatorOTHER

Standard of Care Observation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (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 * Eastern Cooperative Oncology Group (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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction

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.

Time frame: 2 years

Number of Participants With 2-year Recurrence Free Survival

To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.

Time frame: 4 years

Secondary Outcomes

Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)

To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.

Time frame: 4 years

Number of Participants With Adverse Events as a Measure of Safety

To compare participant adverse events between metformin and observation arms using CTCAE version 4.

Time frame: 4 years

Data from ClinicalTrials.gov

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