Early Access Program of Lazertinib in Republic of Korea

February 15, 2022 updated by: Yuhan Corporation

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.

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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 Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (ACTUAL)

April 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASER-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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