Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01717482|
Recruitment Status : Active, not recruiting
First Posted : October 30, 2012
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Carcinoma, Non-Small-Cell Lung||Drug: Metformin Other: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Active Comparator: Metformin
Metformin 850mg BID
Other Name: Glucophage
Placebo Comparator: Observation
Standard of Care Observation
Other: Placebo Comparator
Standard of Care Observation
- 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.
- Measure Metformin Sensitivity in iPS (Induced Pluripotent Stem Cells) [ Time Frame: 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.
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 4 years ]To compare participant adverse events between metformin and observation arms using CTCAE version 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717482
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Dennis Wigle, MD, PhD||Mayo Clinic|