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This is an observational study that investigates why early (primary) resistance develops to first-line third-generation EGFR-TKI drugs in people with EGFR-mutated advanced non-small cell lung cancer, using genetic analyses and circulating tumor DNA (ctDNA). Patients older than 18 with EGFR mutation confirmed by tissue or cytology who are receiving this treatment are included. It is a non-interventional (observational) study and is currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Age \>18 years; 2. Histological or cytopathological diagnosed NSCLC; 3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery; 4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria; 5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.); 6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy; 7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development; 8. Agree to participate in this study and sign an informed consent form. Exclusion Criteria: 1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form; 2. Pregnant and lactating women; 3. Other malignant neoplastic diseases within 3 years; 4. Patients who have undergone other clinical drug trials; 5. Received systemic anti-tumor therapy within 2 years;