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

Sponsor
Fudan University
Study ID
NCT06323148
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Adjuvant osimertinib for three years after radical surgery
  • No adjuvant therapy — DRUG
    No adjuvant therapy

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2029

Study Design

Enrollment
226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: ct-DNA-positive patients receiving no adjuvant osimertinib
    ct-DNA-positive patients receiving no adjuvant osimertinib
  • Experimental: ct-DNA-positive patients receiving adjuvant osimertinib
    ct-DNA-positive patients receiving adjuvant osimertinib

Primary Outcome Measure

The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. [ Time Frame: 3 years ]

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