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.
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
Patients who eligible the inclusion/exclusion criteria should take lazertinib 240 mg (80 mg,
3 tablets) once a day at the same time as possible on an empty stomach before meals. One
cycle of treatment is defined as 42 days of continuous administration, and the tumor response
by RECIST 1.1 will be evaluated every 1 cycle for the 1st, 2nd, 3rd, and 4th evaluation, and
every 2 cycles from the 5th evaluation thereafter. .
If the investigator decides to reduce the dose due to an adverse drug reaction during the
administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of
Efficacy and safety will be evaluated by administering lazertinib 240 mg to patients with
measurable brain metastasis or newly confirmed metastatic non-small cell lung cancer after
failure of treatment with gefitinib, erlotinib, or afatinib after EGFR mutation is confirmed.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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