Early Access Program of Lazertinib in Republic of Korea

• Conditions: Lung Cancer

• Registration Number: NCT04829422
• Lead Sponsor: Yuhan Corporation

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified