Overview

Metformin in Non Small Cell Lung Cancer (NSCLC)

Status:
Terminated

Trial end date:
2019-01-05

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if giving metformin in combination with radiation therapy is more effective than radiation therapy alone. In this study, participants will receive either metformin or a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. This is an investigational study. Metformin is FDA approved for the treatment of diabetes. Its use in this study to be given with radiation therapy to treat lung cancer is investigational. The study doctor can explain how the study drug is designed to work. Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Metformin

Criteria

Inclusion Criteria:

1. Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.

2. Patients are to be treated with hypofractionated RT.

3. Patient is not a surgical candidate due to medical comorbidities determined by a
thoracic surgeon or patient refusal

4. Patient plans to receive treatment at MD Anderson

5. Patients must sign informed consent

6. Patient must have adequate renal function within 30 days prior to registration,
defined as serum creatinine within normal institutional limits or creatinine clearance
at least 60 ml/min

Exclusion Criteria:

1. Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or
insulin at the time of study entry

2. Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/=
1.2 mg/dl

3. Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to
the participant, embryo, fetus, or nursing infant

4. Patients with history of allergic reaction to metformin