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NCT04829422 Clinical Trial

Early Access Program of Lazertinib in Republic of Korea

Lung Cancer Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04829422
Other study ID # LASER-EAP
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date February 2022
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lazertinib 240 mg
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yuhan Corporation
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