A randomized phase 2 study of pemetrexed vs. pemetrexed+erlotinib in second-line treatment for locally advanced or metastatic, non-squamous NSCLC

Background: PEM and ERL have been approved as second-line monotherapy for locally advanced or metastatic NSCLC. The combination of PEM + ERL showed synergistic activity in preclinical studies. This multicenter, randomized, open-label study assessed the efficacy and safety of PEM + ERL vs. PEM. Methods: Patients (pts) with NSQ NSCLC who have failed one prior platinum-based chemotherapy regimen for advanced or metastatic disease, ≥1 measurable lesion by RECIST, and Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 were eligible. Pts received PEM 500mg/m2 (with vitamin B12 and folic acid supplement…