Phase III study of vinflunine versus docetaxel in patients (pts) with advanced non-small cell lung cancer (NSCLC) previously treated with a platinum-containig regimen

Background: Vinfluine (VFL) is a new microtubule inhibitor of the vinca alkaloid class with clinical activity in NSCLC. Single-agent efficacy and safety of VFL and docetaxel (DTX) were compared in the 2nd line chemotherapy. Methods: Open-label, multi-center randomised, phase III study in platinum pre-treated locally advanced/metastatic NSCLC pts. At least 275 pts were to be randomized by arm to receive VFL/320mg/m2, 20-min IV infusion) or DTX (75mg/m2) every 3 weeks. The primary endpoint was progression free survival (PFS), with a non-inferiority analysis based on a 10% difference (types I and II error rates: 5%…