Metformin in Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT02285855

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-20
• Study Completion Date: 2019-01-05

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stereotactic body Radiotherapy (SBRT) + Metformin

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Stereotactic body Radiotherapy (SBRT)

Intervention Type: RADIATION

SBRT delivered per standard of care practice as determined by participant's physician.

Stereotactic Body Radiotherapy (SBRT) + Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.

Stereotactic body Radiotherapy (SBRT)

Intervention Type: RADIATION

SBRT delivered per standard of care practice as determined by participant's physician.

Interventions

Metformin

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.

Intervention Type: DRUG

Placebo

Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.

Intervention Type: OTHER

Stereotactic body Radiotherapy (SBRT)

SBRT delivered per standard of care practice as determined by participant's physician.

Intervention Type: RADIATION

Other Intervention Names

Metformin ER; Sugar pill; SBRT; XRT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen G. Chun, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31990759 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2015-00287

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-0255

Identifier Type: -

Identifier Source: org_study_id