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NOT YET RECRUITING
NCT06323148
PHASE3

Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)

Sponsor: Fudan University

View on ClinicalTrials.gov

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 1:1 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.

Official title: Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

226

Start Date

2024-04-01

Completion Date

2029-03-31

Last Updated

2024-03-21

Healthy Volunteers

No

Interventions

DRUG

Osimertinib

Adjuvant osimertinib for three years after radical surgery

DRUG

No adjuvant therapy

No adjuvant therapy