Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer
Status:
Completed
Trial end date:
2018-11-08
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the safety of different ways of taking erlotinib. The
investigators want to find out what effects, good and/or bad, combination daily low dose and
twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are
also seeing whether different schedules of erlotinib are better at treating lung cancer that
has spread to the central nervous system.
CNS expansion phase:
The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers
and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly
diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the
expansion cohorts will undergo the same treatment plan as the patients in the dose expansion
cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the
first 28 day (cycle 1) treatment period.