Bayer and Onyx are initiating a Phase III study of Nexavar in combination with carboplatin and paclitaxel to treat non-small cell lung cancer.

The study, which FDA reviewed in a Special Protocol Assessment, will compare treatment with carboplatin and paclitaxel plus Nexavar to treatment with the chemotherapy agents alone in roughly 900 patients, the firms said. The study is open to systemic treatment-naive NSCLC patients with any histology, including squamous cell or adeno carcinomas.

Patients will receive 400 mg of oral Nexavar or placebo twice daily plus six cycles of chemotherapy. Nexavar or placebo will continue throughout a maintenance phase.

The primary endpoint of the trial will be overall survival, with secondary endpoints of progression-free survival, tumor response and safety.

Nexavar was approved in December to treat kidney cancer (¹ Also see "Bayer/Onyx’ Nexavar Approved For Kidney Cancer" - Pink Sheet, 20 December, 2005.).

Pfizer's oncologic Sutent (sunitinib), approved for kidney cancer, is currently in Phase II trials for lung cancer.

Nexavar is already in Phase III trials for advanced hepatocellular carcinoma and metastatic melanoma.

-Kathleen Michael

Next For Nexavar: Bayer/Onyx Initiate Phase III Lung Cancer Trial

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