Saito H, et al. - In this phase 3 trial, researchers intended to validate the results of the JO25567 study and describe the findings from the preplanned interim analysis. In the JO25567 phase 2 trial in patients with non-small-cell lung cancer (NSCLC), the activity and manageable toxicity of erlotinib plus bevacizumab were established when this combination therapy was compared to erlotinib monotherapy. Participants included patients with stage IIIB–IV disease or recurrent, cytologically or histologically confirmed non-squamous NSCLC with activating EGFR genomic aberrations, recruited from 69 centres across Japan. Either oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day monotherapy, was randomly administered (1:1) to the patients. For erlotinib plus bevacizumab group vs the erlotinib group, the median progression-free survival at the time of interim analysis was 16·9 months vs 13·3 months, respectively. Overall, improved progression-free survival was provided by bevacizumab plus erlotinib combination therapy vs erlotinib alone in patients with EGFR-positive NSCLC.