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Tyrosine Kinase Inhibitors

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lazertinib 240mg, once a day, oral, before disease progression

- lazertinib 240mg(3tablets, 80mg/1tablet), once a day, oral, before disease progression

lazertinib(YH25448)

Jin Hyoung Kang

SuHyun Jeong

Yu Jung Kim

Hee Kyung Ahn

Ju Won Kim

YoonJi Choi

Bhumsuk Keam

JIN HYOUNG KANG

SoHee Park

Hye Ryun Kim

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.

Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.

Lazertinib in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Metastatic Non-Small Cell Lung Cancer With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR Tyrosine Kinase Inhibitor

iORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.

the date of onset of objective intracranial disease progression or death of any cause, whichever occurs first.

iORR will be evaluated according to RECIST v1.1 after IP administration

ORR will be evaluated according to RECIST v1.1 after IP administration.

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)

the percentage of subjects whose response is CR, PR, responding, or SD.

the period from the first administration of the investigational drug to the date of death from any cause.

intracranial progression or extracranial progression or both

the percentag of subjects who received salvage treatment(surgery or radiation therapy) due to intracranial disease progression.

Spots Global Cancer Trial Database for failure of egfr tki