Combination of Metformin With Gefitinib to Treat NSCLC
NCT01864681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224
Last updated 2018-06-20
Summary
The purpose of this study is to determine whether metformin in combination with gefitinib are effective in patients with previously untreated advanced or metastatic Non-Small-Cell Lung cancer with epidermal growth factor receptor (EGFR) mutations
Conditions
- NSCLC
- EGFR Gene Amplification
- Advanced Cancer
- Stage IIIB NSCLC
- Stage IV NSCLC
Interventions
- DRUG
-
Gefitinib and Metformin
Gefitinib will be administered once every day. If subject has complete response, partial response, stable disease, or unacceptable toxicity.
- DRUG
-
Gefitinib and placebo
Gefitinib will be administered once every day. If subject has complete response, partial response, stable disease, or unacceptable toxicity.
Sponsors & Collaborators
-
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
lead OTHER
Principal Investigators
-
Yong He, MD · Daping Hospital, Third Military Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-06-04
Countries
- China
Study Locations
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