Spots Global Cancer Trial Database for Bevacizumab and Erlotinib in Lung Cancer With Brain Metastases, a Phase II Trial

Study Description

Brief Summary: 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.

Detailed Description: 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. Patients will be randomized, at a 1:1 ratio, into bevacizumab plus erlotinib group or erlotinib alone group. Compute tomography (CT) or MRI scans will be performed every 6 weeks in the first 12 months since start of investigational drugs, and then performed every 12 weeks. Patients will be followed until documented progression at brain and/or extra-cranial lesions. Patients with intracranial progression only are allowed to continue investigational drugs until a second progression of either intracranial progression or extracranial progression, developed, and the time-to extracranial progression will be determined. In patients with EGFR mutant advanced NSCLC who had brain metastases, it was reported that PFS to erlotinib or gefitinib was 6.6 months(Park et al., 2012). In the current study, it is assumed that the median PFS, both intracranial and extracranial included, is 7 months for erlotinib group alone and is 12.3 months for bevacizumab plus erlotinib group (hazard ratio 0.57) (Seto et al., 2014). 109 patients will be required for analysis in this randomized phase II study. Patients will be stratified according to the EGFR L858R mutation and the EGFR exon 19 deletion mutation.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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