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

ConditionsLung Cancer EGFR Gene Mutation Minimal Residual Disease

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than 18 years old, both males and females are eligible.

Histologically confirmed diagnosis of non-small cell lung cancer.

Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th edition TNM staging guidelines combined with radiological evaluation.

EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR or high-throughput sequencing), specifically with mutations 19del or 21L858R.

Disqualifiers

Pathological diagnosis of mixed-type lung cancer (including a history of small cell lung cancer or non-adenocarcinoma).

Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).

Rx, R1, R2 surgical resection.

Received blood transfusion during surgery or within 2 weeks before surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

Osimertinib
Drug
Adjuvant osimertinib for three years after radical surgery
No adjuvant therapy
Drug
No adjuvant therapy

Treatment groups

226 Participants

are divided into 2 treatment groups

Group A: ct-DNA-positive patients receiving no adjuvant osimertinibPlacebo comparator 1 intervention

Group B: ct-DNA-positive patients receiving adjuvant osimertinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group.

Disease-Free Survival

Time frame

3 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: