Metastatic Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms,
administering the study drug during radiotherapy and following radiotherapy until disease
progression, unacceptable toxicity or at the discretion of the physician. Randomization will
be done 2:1 (experimental:control). Chemotherapy can be added before documented disease
progression at the discretion of the physician.
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The
primary endpoint is intracranial disease progression over 6 months.
The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or
death with evidence of neurologic progression; OS rate at 6 months; time to intracranial
disease progression; and time to overall progression.
Tissue samples and serum will be collected for future correlative studies.
All the images will be centrally reviewed at the end of study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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