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

Inclusion criteria

• 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.
• Able to undergo R0 surgical resection.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1. Expected survival of more than 12 months.
• Baseline blood routine and biochemical indicators meeting the following criteria:

• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
• Lymphocyte count ≥ 0.5 × 10^9/L;
• Platelet count ≥ 100 × 10^9/L;
• Hemoglobin ≥ 9 g/dL.
• Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times ULN.
• Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.

Exclusion criteria

• 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.
• Pregnant or lactating female patients.
• History of other malignant tumors within the past 5 years, except for cases where other malignant tumors have been cured solely through surgery with a disease-free interval of at least 10 years, curable basal cell carcinoma of the skin, and cervical carcinoma in situ.
• Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases).
• Evidence of any other diseases, neurological or metabolic functional disorders, physical examination findings, or laboratory findings that would place the subject at high risk of treatment-related complications.
• Other factors deemed by the investigators to potentially affect the study process.