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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

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Trial Information

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


Patients will be identified and enrolled from Thoracic Surgical Clinics. A preoperative
bronchoscopy will be performed to obtain systematic bronchial biopsies from defined proximal
airway sites. Patients will then undergo surgical resection and tumor tissue and normal lung
specimens collected. For patients with bronchial dysplasia postoperatively, starting less
than 90 days from the time of surgery, patients will be randomized to receive either 850 mg
po BID of metformin or observation. Metformin dosing will include a 4 week ramp up of 850 mg
po daily prior to starting the BID dose. Adjuvant platinum-based chemotherapy will be
applied at the discretion of treating physicians. Patients found to have bronchial
dysplasia at the time of bronchoscopy will undergo follow up bronchoscopy and tissue
sampling at 6 months follow up.

Inclusion Criteria


Inclusion Criteria

- Suspected or biopsy proven Stage IB-IIIA NSCLC

- Coincident bronchial dysplasia and/or carcinoma in situ from at least 1 non-resected
location

- 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

- ECOG performance status 0, 1, 2

Exclusion Criteria

- Prior neoadjuvant therapy

- Existing untreated or prior cancer <5 years from diagnosis

- Diabetic

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Participants Screened

Outcome Description:

To evaluate the feasibility of patient randomization and accrual in a pilot study of metformin versus observation following resection of stage IB-IIIA lung squamous cell cancer for patients with coincident bronchial dysplasia by collecting data on the number of participants screened.

Safety Issue:

No

Principal Investigator

Dennis Wigle, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

12-006865

NCT ID:

NCT01717482

Start Date:

October 2012

Completion Date:

May 2014

Related Keywords:

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Bronchoscopy
  • Metformin
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Mayo Clinic in Rochester Rochester, Minnesota  55905