A randomized phase II study of sorafenib/gemcitabine or sorafenib/erlotinib for advanced non-small-cell lung cancer in elderly patients or patients with a performance status of 2: treatment rationale and protocol dynamics

Abstract

Herein, we present a randomized phase II trial enrolling elderly patients or patients with a performance status (PS) of 2 affected by advanced non-small-cell lung cancer to receive, as first-line therapy, sorafenib/gemcitabine or sorafenib/erlotinib. The primary objective is 1-year survival, and secondary objectives include activity, toxicity, and overall survival. An additional secondary objective will be to evaluate biomarkers. Sample size is calculated on the basis of theory of selection. The study will enroll 100 patients: 58 patients aged >or= 70 years with a PS of 0-2 and 42 patients aged < 70 years with a PS of 2. The analysis will be conducted differently for the 2 groups of patients.