NCT01646450

First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 70 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

Detailed description

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR. * Primary endpoint to assess progression-free survival * Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib	Icotinib: 125mg, oral administration, three times per day.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-12-01
• Completion: 2016-04-01
• First posted: 2012-07-20
• Last updated: 2015-09-09

Locations

1 site across 1 country: China