Early Access Program for Lazertinib in South Korea

Sponsor: Yuhan Corporation

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04829422

Provider View

This program provides early access to Lazertinib for adults with advanced Non-small Cell Lung Cancer (NSCLC) who have a specific genetic mutation and have previously been treated with certain cancer therapies.

Patient Parameters

Program Overview

The purpose of this program is to offer Lazertinib, a targeted cancer treatment, to patients in South Korea with advanced Non-small Cell Lung Cancer (NSCLC) that has a specific genetic mutation known as T790M. This mutation occurs after treatment with earlier types of EGFR-targeting therapies. Lazertinib is designed to target and block the cancer-causing mutations while avoiding normal cells. The program aims to evaluate the safety and effectiveness of Lazertinib as a second-line treatment in a real-world setting.

Description

Lazertinib is a medication taken by mouth that specifically targets and blocks certain mutations in the EGFR gene, which are known to drive the growth of some lung cancers. It is particularly effective against the T790M mutation, which can develop after initial treatments with other EGFR-targeting drugs. This program is being conducted across multiple centers in South Korea to provide early access to Lazertinib for patients with advanced Non-small Cell Lung Cancer (NSCLC) who have this mutation. The goal is to gather information on how safe and effective Lazertinib is when used as a second-line treatment in everyday clinical practice.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 19 years old.
  • Must agree to allow the use of personal and medical information for the study.
  • Must be prescribed Lazertinib for an approved use in South Korea and have not been treated with Lazertinib before.

Exclusion Criteria

  • Have an allergy to Lazertinib or any of its ingredients.
  • Have conditions listed as contraindications on the Lazertinib label in South Korea.
  • Are being treated for a condition not approved for Lazertinib use.
  • Are pregnant or could become pregnant.

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