A safety and efficacy trial of sorafenib (400 mg twice daily) in chemotherapy-naive patients with nonsquamous stage IIIB non-small-cell lung cancer has shown the treatment to be no better than the control regimen of gemcitabine (1,250 mg/m2 per day on days 1 and 8) and cisplatin (75 mg/m2 on day 1). The trial of 772 patients (385 in the sorafenib group and 387 in the control group), with similar demographic and baseline characteristics in both arms, demonstrated similar overall survival (12.4 months versus 12.5 months, hazard ratio 0.98, P = 0.401). Furthermore, sorafenib was associated with increased adverse events that included hand–foot skin reactions (8.6% versus 0.3%), fatigue (7.3% versus 3.6%) and hypertension (4.2% versus 1.8%).