Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

• Age greater than or equal to 18
• Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
• At least one brain metastasis diagnosed within 30 days of randomization
• Brain metastases must not have been previously treated with WBRT or radiosurgery
• No more than 2 sites of extracranial metastases
• May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites
• Meets protocol requirements for specified laboratory values.
• Written informed consent and cooperation of patient
• Appropriate use of effective contraception if of childbearing potential.
• Karnofsky Performance Status KPS greater than 70
• Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)