Early Access Program of Lazertinib in Republic of Korea

N/AApproved For MarketingNCT04829422

Yuhan Corporation

Overview

This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs Therapy.

Lazertinib is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. This is a Multi-center, Prospective, Early Access Program of Lazertinib in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with T790M mutation-positive after 1st/2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment.

Study Type

EXPANDED_ACCESS

Conditions

Lung Cancer

Interventions

Lazertinib 240 mgDRUG

The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged at least 19 years * Patients who have written consent for use of personal and medical information for the study purpose * Patients who are prescribed and administered with approved indication for Lazerinib in Korea and not been treated with Lazertinib previously. Exclusion Criteria: * Patients with hypersensitivity to Lazertinib or its any ingredients * Patients who belong to contraindication listed on lazertinib label in Korea * Patients who are treated for an indication not approved for the use of Lazertinib * Women who are pregnant or may possibly become pregnant

Data from ClinicalTrials.gov

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