Early Access Program of Lazertinib in Republic of Korea

Yuhan

Status

Conditions: Lung Cancer

Treatments: Drug: Lazertinib 240 mg

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04829422

LASER-EAP

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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