Metformin in Non Small Cell Lung Cancer (NSCLC)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 6, 2020 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- M.D. Anderson Cancer Center
- Interventions being studied
- Drug: Metformin; Other: Placebo; Radiation: Stereotactic body Radiotherapy (SBRT)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2020. Always confirm current availability with the study team.