NCT01864681

Combination of Metformin With Gefitinib to Treat NSCLC

A Phase II, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination of Gefitinib and Metformin in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary Objectives: To determine the 1 year progression-free survival (PFS) of the combination of metformin and gefitinib in patients who harbors EGFR-mutant with previously untreated advanced or metastatic pulmonary adenocarcinoma. Secondary Objectives: A. To evaluate the response to therapy and overall survival of the combination of metformin with gefitinib in patients who harbors EGFR-mutant with previously untreated advanced or metastatic pulmonary adenocarcinoma. B. To acquire preliminary data regarding the effects of metformin on interleukin-6 (IL-6) levels in tumor and serum. Treatment will be administered on an outpatient basis. Metformin starting at a dose of 500 mg twice a day, orally with meals. After one week, increase the dose of metformin to 1000 mg as the first dose of the day and 500 mg as the second dose. After another week, increase to 1000 mg of metformin two times a day. Metformin treatment will be initiated one week before beginning gefitinib, if possible, but gefitinib administration will not be delayed for metformin loading. Gefitinib will be administered 250mg QD continuously. Metformin will be administered continuously, beginning one week before beginning gefitinib, if possible, but tyrosine kinase inhibitors (TKI) will not be delayed for metformin loading. Maintenance Therapy Patients responding to this therapy will be maintained with metformin (1000 mg twice daily) and gefitinib. Duration of Therapy In the absence of treatment delays due to adverse events, treatment may continue until one of the following criteria applies: 1. Disease progression, 2. Intercurrent illness that prevents further administration of treatment, 3. Unacceptable adverse events(s), 4. Patient decides to withdraw from the study, or 5. General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Conditions

• NSCLC
• EGFR Gene Amplification
• Advanced Cancer
• Stage IIIB NSCLC
• Stage IV NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-12-01
• Completion: 2018-06-04
• First posted: 2013-05-29
• Last updated: 2018-06-20

Locations

1 site across 1 country: China