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

NCT05326425 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-04-20

No results posted yet for this study

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

Conditions

  • Lung Neoplasms

Interventions

DRUG

lazertinib(YH25448)

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

Sponsors & Collaborators

  • Jin Hyoung Kang

    lead OTHER

Principal Investigators

  • Jin Hyoung Kang · Seoul St. Mary's Hospital, The Catholic University of Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326425 on ClinicalTrials.gov