- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829422
Early Access Program of Lazertinib in Republic of Korea
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.
Study Overview
Status
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
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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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