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
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 lazertinib. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
\- lazertinib 240mg(3tablets, 80mg/1tablet), once a day, oral, before disease progression
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
RECRUITINGGachon University Gil Medical Center
Incheon, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeoul St. Mary's Hospital, Catholic University of Korea
Seoul, South Korea
RECRUITINGYonsei University Health System, Severance Hospital
Seoul, South Korea
RECRUITINGIntracranial objective response rates (iORR) (RECIST1.1)
iORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
intracranial progression free survival, iPFS
the date of onset of objective intracranial disease progression or death of any cause, whichever occurs first.
Time frame: Up to 2 years
iORR in T790M negative, isolated CNS progression patient group
iORR will be evaluated according to RECIST v1.1 after IP administration
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
overall ORR
ORR will be evaluated according to RECIST v1.1 after IP administration.
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
duration of response, DoR
Duration from the date of the first documented confirmatory response(CR or PR) to the date of documented disease progression or death (equivalent to the date of the PFS event)
Time frame: Up to 2 years
disease control rate, DCR
the percentage of subjects whose response is CR, PR, responding, or SD.
Time frame: Up to 2 years
overall survival, OS
the period from the first administration of the investigational drug to the date of death from any cause.
Time frame: Up to 2 years
treatment failure pattern
intracranial progression or extracranial progression or both
Time frame: From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
salvage intracranial treatment rate
the percentag of subjects who received salvage treatment(surgery or radiation therapy) due to intracranial disease progression.
Time frame: Up to 2 years
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