Early Access Program of Lazertinib in Republic of Korea
Sponsor: Yuhan Corporation
ClinicalTrials ID:NCT04829422
This early access program evaluates Lazertinib, a selective EGFR TKI, in NSCLC patients with T790M mutation post-1st/2nd gen EGFR TKI therapy. Eligible participants are adults aged 19+, consenting to data use, and previously untreated with Lazertinib. The intervention involves a daily 240 mg dose, adjustable to 160 mg if needed, to assess safety and efficacy.
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Program 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.
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.
Eligibility Criteria
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
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