Bayer/Onyx launch Ph III Nexavar trial

German pharmaceutical group Bayer and the USA's Onyx Pharmaceuticals have initiated a randomized, double-blind, placebo-controlled Phase III clinical trial studying their co-developed cancer drug Nexavar (sorafenib) administered with two common chemotherapeutic agents in patients with non-small cell lung cancer.

The pivotal multicenter study will compare the oral multikinase inhibitor when co-administered with carboplatin and paclitaxel versus carboplatin and paclitaxel alone. The program, which is expected to enroll 900 patients, will assess overall survival as the primary endpoint, while secondary endpoints include progression-free survival, tumor response and safety. Patients will be randomized to receive 400mg of oral Nexavar twice-daily or matching placebo, in addition to carboplatin and paclitaxel for six cycles. Subsequently, patients will continue in a maintenance phase where Nexavar or placebo will be administered as a single agent.

Bayer and Onyx have also reported that the US Food and Drug Administration has completed a Special Protocol Assessment for the Phase III NSCLC trial, which means that the design and size of the study will form the basis for any eventual New Drug Application.