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Early Access Program of Lazertinib in Republic of Korea

Sponsor
Yuhan Corporation (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT04829422
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lazertinib 240 mg

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 Design

Study Type:
Expanded Access
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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT04829422
    Other Study ID Numbers:
    • LASER-EAP
    First Posted:
    Apr 2, 2021
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Lung Neoplasms
    Lazertinib

    Study Results

    No Results Posted as of Mar 3, 2022