A Phase 2 interventional study of Metformin and Placebo in Lung Cancer, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to Metformin treatment receive Metformin for 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Metformin administered 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. SBRTdelivered per standard of care practice.
Drug: Metformin · Radiation: Stereotactic body Radiotherapy (SBRT)
Participants randomized to placebo treatment 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.
Other: Placebo · Radiation: Stereotactic body Radiotherapy (SBRT)
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.
Also known as: Metformin ER
Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.
Also known as: Sugar pill
SBRT delivered per standard of care practice as determined by participant's physician.
Also known as: SBRT, XRT
RECIST and PERCIST Tumor Response
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 in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).
Time frame: From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months
A total of 18 lung non-small cell lung cancer (NSCLC) patients were consented and randomized. Eligible criteria: pathologic diagnosis of AJCC Stage I-II, cT1-T2N0M0, can be treated with hypofractionated radiotherapy, not a surgical candidate, have adequate renal function within 30 days prior to registration, and plans to receive treatment at MDACC.
| Milestone | Metformin Arm | Placebo Arm |
|---|---|---|
| Started | 16 | 2 |
| Randomized | 16 | 2 |
| Completed | 14 | 1 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
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 in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).
| Participants | Metformin Arm | Placebo Arm |
|---|---|---|
| Mid-treatment RECIST tumor response (SD) | 14 | 1 |
| Post-treatment (6 mo.) RECIST tumor response(CR) | 7 | 1 |
| Post-treatment (6 mo.) RECIST tumor response(PR) | 3 | 0 |
| Post-treatment (6 mo.) RECIST tumor response(SD) | 3 | 0 |
| Mid-treamtment PERCIST tumor response: (SMD) | 6 | 1 |
| Mid-treamtment PERCIST tumor response: (PMD) | 6 | 0 |
| Mid-treamtment PERCIST tumor response: (PMR) | 2 | 0 |
| Post- treatment (6 mo.) PERCIST (CMR) | 9 | 1 |
| Post- treatment (6 mo.) PERCIST (PMD) | 1 | 0 |
| Post- treatment (6 mo.) PERCIST (PMR) | 3 | 0 |
Collected over From the time of registration through study completion and follow up, assessed up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin Arm | 1/14 (7.1%) | 1/14 (7.1%) | 0/14 (0%) |
| Placebo Arm | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Metformin Arm | Placebo Arm |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/14 | — |
A total of 18 stage I non-small cell lung cancer (NSCLC) patients were consented and randomized. Metformin Arm 16 patients and Placebo Arm 2 patients.
| Age, Categorical(Participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 13 | 2 | 15 |
| Age, Continuous(Years) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| Median | 73.3 (52 to 84) | 69.3 (68 to 71) | 71.3 (52 to 84) |
| Sex: Female, Male(Participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| Female | 9 | 1 | 10 |
| Male | 7 | 1 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 14 | 2 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 14 | 2 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| United States | 16 | 2 | 18 |
| Total 15 patients completed treatment under the protocol and evaluable for data analysis.(Participants) | Metformin Arm | Placebo Arm | Total |
|---|---|---|---|
| (AJJC) Disease Stage 1A | 3 | 1 | 4 |
| (AJJC) Disease Stage 1B | 11 | 0 | 11 |
| (AJJC) Disease T Stage T1a | 2 | 1 | 3 |
| (AJJC) Disease T Stage T1b | 1 | 0 | 1 |
| (AJJC) Disease T Stage T2a | 11 | 0 | 11 |
| Tumor Histology Adenocarcinoma | 9 | 1 | 10 |
| Tumor Histology Squamous Cell Carcinoma | 4 | 0 | 4 |
| Tumor Histology Poorly differentiated carcinoma | 1 | 0 | 1 |
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M.D. Anderson Cancer Center