MRD-Guided Aumolertinib-Based Adjuvant Therapy for Resected EGFR-Mutant NSCLC

1. Provision of written informed consent before any study-related examination, sampling, or analysis.
2. Age ≥18 years.
3. Histologically confirmed primary non-squamous non-small cell lung cancer after surgery, stage IIA-IIIB (8th edition AJCC), with complete (R0) resection.
4. EGFR exon 19 deletion and/or exon 21 L858R mutation detected by histological or cytological testing.
5. Complete recovery from surgery at the time of initiating aumolertinib-containing adjuvant therapy; the interval between surgery and initiation of aumolertinib-containing adjuvant therapy must not exceed 10 weeks; complete postoperative wound healing; and recovery from all toxicities of prior therapy greater than CTCAE grade 1 at the start of study treatment, except for alopecia and grade 2 platinum-related neuropathy.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Adequate bone marrow and organ function: absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin >9 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; total bilirubin ≤1.5×ULN; serum creatinine ≤1.5×ULN with creatinine clearance (Cockcroft-Gault formula) ≥60 mL/min.
8. Adequate coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, i.e., PT ≤19.5 seconds or INR ≤1.8.
9. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first dose of study drug. Women not of childbearing potential are defined as postmenopausal for at least 1 year, or surgically sterilized, or having undergone hysterectomy.
10. If there is a risk of conception, all participants (male or female) must use highly effective contraception throughout the treatment period and for 120 days after the last dose of study drug.

Exclusion Criteria:

1. Receipt of any of the following: radiotherapy (preoperative, postoperative, or planned) for the current lung cancer; preoperative (neoadjuvant) platinum-based or other chemotherapy; any prior antitumor therapy other than standard platinum-based doublet adjuvant chemotherapy, including investigational therapy; prior neoadjuvant or adjuvant EGFR-TKI therapy; major surgery within 4 weeks before the first dose of study drug; or current use (or inability to discontinue at least 3 weeks before the first dose) of drugs or herbal supplements known to be strong CYP3A4 inducers. Chinese herbal medicines used solely for conditioning or nourishment do not affect enrollment.
2. Segmentectomy or wedge resection, or failure to perform lymph node dissection.
3. Prior interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; or idiopathic pulmonary fibrosis detected on baseline CT.
4. Diagnosis of another malignancy within 2 years before the first dose (except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ with ≥5 years of continuous monitoring without recurrence).
5. Any unstable systemic disease, including: active infection; autoimmune disease requiring drug treatment or plasmapheresis; uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg); unstable angina or angina of new onset within the last 3 months; myocardial infarction (within 6 months before enrollment) or ongoing warfarin anticoagulation after cardiac stent implantation; uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or pulmonary hypertension; renal insufficiency requiring dialysis; insufficient organ reserve; type 1 diabetes mellitus, or type 2 diabetes mellitus complicated by renal or cardiovascular disease or diabetic foot, or a history of ketoacidosis, lactic acidosis, hyperosmolar hyperglycemic state, or random blood glucose ≥11.1 mmol/L; and cardiac findings meeting any of the following: mean resting corrected QT interval (QTc) >470 msec from 3 ECGs (using QTcF), any clinically important abnormality of cardiac rhythm, conduction, or morphology on resting ECG (such as complete left bundle branch block, third-degree or second-degree atrioventricular block), or any factor increasing the risk of QTc prolongation or arrhythmia (such as heart failure ≥ New York Heart Association class II, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval).
6. NSCLC with large cell neuroendocrine carcinoma or sarcomatoid carcinoma histology.
7. Known allergy or hypersensitivity to aumolertinib, to compounds of similar structure, or to any of its excipients.
8. Mixed small cell lung cancer.
9. Pregnant or breastfeeding women.
10. Uncontrolled nausea and vomiting, chronic gastrointestinal disease, inability to swallow the drug product, or prior major bowel resection that may affect adequate absorption of aumolertinib.
11. Any condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.