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

Sponsor
Jin Hyoung Kang
Study ID
NCT05326425
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lazertinib(YH25448) — DRUG
    \- lazertinib 240mg(3tablets, 80mg/1tablet), once a day, oral, before disease progression

Study Details

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

Key Dates

Start date
Jun 23, 2021
Status verified
Apr 2022
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lazertinib(YH25448)
    lazertinib 240mg, once a day, oral, before disease progression

Primary Outcome Measure

Intracranial objective response rates (iORR) (RECIST1.1) [ 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 ]

Central Contacts

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