Clinical trial NCT02285855: Metformin in Non Small Cell Lung Cancer (NSCLC)
Official title: Tumor Mutation Status Will Predict Metabolic Response to Metformin in Non Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: RECIST and PERCIST Tumor Response
timeFrame: From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Stephen G. Chun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chun SG, Liao Z, Jeter MD, Chang JY, Lin SH, Komaki RU, Guerrero TM, Mayo RC, Korah BM, Koshy SM, Heymach JV, Koong AC, Skinner HD. Metabolic Responses to Metformin in Inoperable Early-stage Non-Small Cell Lung Cancer Treated With Stereotactic Radiotherapy: Results of a Randomized Phase II Clinical Trial. Am J Clin Oncol. 2020 Apr;43(4):231-235. doi: 10.1097/COC.0000000000000632.