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

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.

Timeline

Start

2013-07

Primary completion

2016-06

Completion

—

Outcome

Missed primary endpoint

paper DCR with erlotinib and gefitinib were 91% [95% CI 81.7-95.3] and 93% [85.1-96.6], respectively (P = 0.613). PMID 33244458 ↗

Publications

• Zhao S, Zhang Z, Fang W, Zhang Y, Zhang Z, Hong S, Ma Y, Zhou T, Yang Y, Huang Y, Zhao H, Zhang L. Efficacy and Tolerability of Erlotinib 100 mg/d vs. Gefitinib 250 mg/d in EGFR-Mutated Advanced Non-small Cell Lung Cancer (E100VG250): An Open-Label, Randomized, Phase 2 Study. Front Oncol. 2020 Nov 10;10:587849. doi: 10.3389/fonc.2020.587849. eCollection 2020.

Drugs

Indications