NCT01955421

Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc

A Randomized, Open-label Phase II Trial of Erlotinib 100mg Daily Versus Gefitinib 250mg Daily in Patients With Advanced Non-small Cell Lung Cancer Who Harbor EGFR Mutations.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression. Independent assessment of the major endpoints will be completed in a treatment-blinded manner. Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs. second-line therapy). Tumor response and progression will be assessed according to RECIST 1.1.

Conditions

• Advanced Stage Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib 100mg qd
DRUG	Gefitinib 250mg qd

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-06-01
• First posted: 2013-10-07
• Last updated: 2015-07-03

Locations

1 site across 1 country: China