Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829422
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2022-03-03
First Post:
2021-03-30
Brief Title:
Early Access Program of Lazertinib in Republic of Korea
Sponsor:
Yuhan Corporation
Organization:
Yuhan Corporation
Study Overview
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 1st2nd Generation EGFR TKIs Therapy to Assess the Safety and Efficacy of Real World Evidence
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1st2nd 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 1st2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment
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 1st2nd generation EGFR TKIs therapy to assess the safety and efficacy of real world evidence as second-line treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None