Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ct-DNA-positive patients receiving no adjuvant osimertinib | Placebo Comparator | ct-DNA-positive patients receiving no adjuvant osimertinib |
|
| ct-DNA-positive patients receiving adjuvant osimertinib | Experimental | ct-DNA-positive patients receiving adjuvant osimertinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib | Drug | Adjuvant osimertinib for three years after radical surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. | Disease-Free Survival | 3 years |
Not provided
Not provided
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:
Patients must provide informed consent, either directly or through their legally authorized representatives, after being informed about the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596361 | osimertinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No adjuvant therapy | Drug | No adjuvant therapy |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |