Metformin in Non Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Metformin; Placebo; Stereotactic body Radiotherapy (SBRT)
Intervention description: Metformin treatment given at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week.; Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.; SBRT delivered per standard of care practice as determined by participant's physician.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Non small cell lung cancer; Stereotactic body radiotherapy; SBRT; XRT; Radiation therapy; Metformin; Metformin ER; Placebo; Sugar pill; Lung adenocarcinoma; Genotypes; Genetic mutations

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.
    

Eligibility 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