NCT01024413

Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations

A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Chinese Society of Lung Cancer · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).

Detailed description

Patients with stage IV NSCLC who have EGFR exon 19 or 21 mutations will randomized to received oral erlotinib 150mg or gefitinib 250mg once daily until disease progression or unacceptable toxicity. Method of direct DNA sequencing of tumor tissue is used to analysis EGFR mutation status of exons 18-21. The response will be evaluated by RECIST criteria first month,second month and then repeat every 3 months after the beginning of the treatment weeks.

Conditions

• Thoracic Neoplasms

Interventions

Type	Name	Description
DRUG	erlotinib	study arm.erlotinib 150 mg oral till disease progression
DRUG	gefitinib	study arm.gefitinib 250 mg oral till disease progression

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2009-12-02
• Last updated: 2017-03-01

Locations

1 site across 1 country: China