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

Phase 2

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
• Interventions: Other: Placebo Comparator; Drug: Metformin

• Registration Number: NCT01717482
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2019-05-22
• Study Completion: 2019-05-22
• Results First Submitted: 2019-05-28
• Results First Submitted QC: 2019-05-28
• Results First Posted: 2019-06-19
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observation	Placebo Comparator	Standard of Care Observation
Metformin	Metformin	Metformin 850mg twice a day

Primary Outcome Measures

Name	Time	Method
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction	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	4 years	To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety	4 years	To compare participant adverse events between metformin and observation arms using CTCAE version 4.
Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)	4 years	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States