Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268210
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-08
Brief Title:
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer NeoLazer a Phase II Randomized Multi-center Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
NeoLazer
Brief Summary:
In the randomized multicenter Phase II clinical trial we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable treatment-naive EGFR-mutant exon 19 deletion or exon 21 L858R non-small cell lung cancer ranging from clinical stage IB to IIIB The study is designed to assess the impact on pathological response as well as effectiveness and safety considerations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None