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

Mayo Clinic

Status and phase: Terminated; Phase 2

Conditions: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Metformin; Other: Placebo Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01717482

12-006865

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups, including a placebo group

Metformin

Active Comparator group

Description:

Metformin 850mg twice a day

Treatment:

Drug: Metformin

Observation

Placebo Comparator group

Description:

Standard of Care Observation

Treatment:

Other: Placebo Comparator