Bayer, Onyx Begin Cancer Trial

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. have initiated a randomized, double-blind, placebo-controlled Phase III trial studying Nexavar tablets administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC).

The multicenter study will compare Nexavar when co-administered with two chemotherapeutic agents—carboplatin and paclitaxel—versus carboplatin and paclitaxel alone. The study is expected to enroll approximately 900 patients and will assess overall survival as the primary endpoint. Secondary endpoints include progression-free survival, tumor response and safety. Participating patients may not have received prior systemic anticancer treatment. Additionally, the study is open to patients with all histologies, or types, of NSCLC including those with squamous cell or adeno carcinomas. The study will be conducted at more than 130 sites in North America, South America, Europe and the Asia Pacific region.

The FDA has completed a SPA for the Phase III NSCLC trial. A SPA is a written agreement on the design and size of a clinical trial intended to form the basis for a new drug application.