Spots Global Cancer Trial Database for Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc

Official Title: 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.

Study ID: NCT01955421

Conditions

Advanced Stage Non Small Cell Lung Cancer

Interventions

Erlotinib 100mg qd

Gefitinib 250mg qd

Study Description

Brief 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.

Detailed Description: