This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases. The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.
Name: Bevacizumab plus erlotinib
Name: Erlotinib
Description: The PFS will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.
Measure: Progression-free survival Time: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.Description: The response rate will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.
Measure: overall response rate Time: The response rate will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.Description: The Time-to- CNS progression will be evaluated from date of randomization until the date of documented CNS progression.
Measure: Time-to-central nervous system (CNS) progression Time: Time-to-central nervous system(CNS) progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.Description: The Time-to-extra-CNS progression will be evaluated from date of randomization until the date of documented extra-CNS progression.
Measure: Time to extra-CNS progression Time: Time to extra-CNS progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.Description: The PFS-2 will be evaluated from date of randomization until the date of second documented progression or the date of death from any cause, whichever came first.
Measure: The PFS-2 in patients in patients with CNS progression only Time: The PFS-2 will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.Description: Time to neurological symptom will be assessed from date of randomization until the dated of documented progression of neurological symptom.
Measure: Time to neurological symptom progression Time: Time to neurological symptom progression will be evaluated every 3 weeks up to 36 months.Allocation: Randomized
Parallel Assignment
There is one SNP
- A tumor harboring an EGFR mutation known to be associated with erlotinib sensitivity (exon 19 deletion and L858R) - Documented brain metastases. --- L858R ---
Patients will be stratified according to the EGFR L858R mutation and the EGFR exon 19 deletion mutation. --- L858R ---