Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
This is an open-label, single-intervention, multicenter clinical trial in patients with
non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after
failure of EGFR TKI treatment. The objective of this study is as follows.
- Primary objective : intracranial objective response rate (iORR) with RECIST 1.1
- Secondary objectives : intracranial progression free survival(iPFS), Intracranial
objective response rate in T790M negative, isolated CNS progression patient group,
overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control
rate(DCR), treatment failure pattern): intracranial progression or extracranial
progression or both, salvage intracranial treatment rate, safety and tolerability