Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323148
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-14
Brief Title:
Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer ECTOP-1022
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA N1-N2 NSCLC patients after radical surgery R0 resection Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics After receiving or not receiving standard adjuvant chemotherapy patients will be randomly assigned in a 11 ratio to either the observation follow-up group experimental group or the osimertinib adjuvant treatment group control group The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA N1-N2 NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors
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