Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose
erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced
non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control
rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224
eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib
250mg daily in a 1:1 ratio until patients experience disease progression. Independent
assessment of the major endpoints will be completed in a treatment-blinded manner.
Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs.
second-line therapy). Tumor response and progression will be assessed according to RECIST
1.1.