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

A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
• Intervention / Treatment: Drug: Metformin; Other: Placebo Comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin; Metformin 850mg twice a day	Drug: Metformin; Other Names: Glucophage
Placebo Comparator: Observation; Standard of Care Observation	Other: Placebo Comparator; Standard of Care Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Alliance for Clinical Trials in Oncology

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 22, 2019
• Study Completion (Actual): May 22, 2019

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Metformin; Bronchoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 12-006865