Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Conditions
Keywords
Bronchoscopy, Metformin
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.
Interventions
DRUGMetformin
OTHERPlacebo Comparator
Standard of Care Observation
Sponsors
Alliance for Clinical Trials in Oncology
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metformin Metformin 850mg twice per day
Metformin | 4 |
| Observation Standard of Care Observation
Placebo Comparator: Standard of Care Observation | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Metformin | Observation | Total |
|---|---|---|---|
| Age, Continuous | 63.25 years STANDARD_DEVIATION 6.87 | 62.5 years STANDARD_DEVIATION 7.5 | 63 years STANDARD_DEVIATION 7.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 1 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
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
Population: Study terminated due to poor accrual and funding ended
Primary
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
Population: Study terminated due to poor accrual and funding ended
Secondary
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
Population: Study terminated due to poor accrual and funding ended
Secondary
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
Population: Study terminated due to poor accrual and funding ended