Dimitris Voliotis, Vice President, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals, said: Nexavar has proven efficacy in liver cancer and kidney cancer and we are committed to researching Nexavar in a variety of other solid tumors,
Based on the results of a signal generating Phase 2 study, Bayer and Onyx initiated this Phase 3 trial to evaluate Nexavar in non-small cell lung cancer, he added.
The Monotherapy administration of Sorafenib in patients with NSCLC trial, is an international multicenter study that will enroll approximately 850 patients.
In addition, the patients will be randomized to receive either Nexavar as single agent or placebo. The primary endpoint of this trial is overall survival, and secondary endpoints include progression-free survival and overall response rate. The safety and tolerability of the two treatment groups will also be compared.
Phase-III trial will be conducted at more than 120 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan.
Laura Brege, Executive Vice President and Chief Operating Officer at Onyx Pharmaceuticals, said: As the leading cause of cancer deaths worldwide, lung cancer is a complex disease that requires new therapeutic options for patients.