18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
RECIST and PERCIST Tumor ResponsePrimary· From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months
The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using \[18F\]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria
Mid-treatment RECIST tumor response (SD)
Group
Value
95% CI
Metformin Arm
14
Placebo Arm
1
Post-treatment (6 mo.) RECIST tumor response(CR)
Group
Value
95% CI
Metformin Arm
7
Placebo Arm
1
Post-treatment (6 mo.) RECIST tumor response(PR)
Group
Value
95% CI
Metformin Arm
3
Placebo Arm
0
Post-treatment (6 mo.) RECIST tumor response(SD)
Group
Value
95% CI
Metformin Arm
3
Placebo Arm
0
Mid-treamtment PERCIST tumor response: (SMD)
Group
Value
95% CI
Metformin Arm
6
Placebo Arm
1
Mid-treamtment PERCIST tumor response: (PMD)
Group
Value
95% CI
Metformin Arm
6
Placebo Arm
0
Mid-treamtment PERCIST tumor response: (PMR)
Group
Value
95% CI
Metformin Arm
2
Placebo Arm
0
Post- treatment (6 mo.) PERCIST (CMR)
Group
Value
95% CI
Metformin Arm
9
Placebo Arm
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of registration through study completion and follow up, assessed up to 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
· Phase 1
· not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
· Phase 3
· not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV
· Phase 2
· not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women
· Phase 2, PHASE3
· not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma
· Phase 2
· not yet recruiting
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 6 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02285855.