Back to resultsEarly Access Program of Lazertinib in Republic of Korea
Primary Purpose
Lung Cancer
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Lazertinib 240 mg
Sponsored by
About this trial
This is an expanded access trial for Lung Cancer
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04829422
Brief Title
Early Access Program of Lazertinib in Republic of Korea
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.
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lazertinib 240 mg
Other Intervention Name(s)
Leclaza 240 mg
Intervention Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
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
12. IPD Sharing Statement
Learn more about this trial
Early Access Program of Lazertinib in Republic of Korea
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