Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs

1. Age ≥ 18 and ≤ 75.

2. Life expectancy exceeding 3 months.

3. Histologic or cytologic pathology confirmed non-small cell lung cancer. However, sputum cytology results alone are not acceptable. The cytology results of tracheal swabbing, tracheal irrigation fluid and needle aspiration are acceptable.

4. Investigators have confirmed the presence of at least one intracranial measurable lesion according to RECIST 1.1 criteria.

5. Patients with stage IV NSCLC with intracranial metastases at MR baseline.

6. Eastern Oncology Collaborative Group (ECOG) fitness status score of 0 or 1.

7. Genetic testing suggests EGFR driver gene positivity, which can be accompanied by other driver gene positivity.

8. Oligo-progression of intracranial tumors at the most recent evaluation following treatment with third- generation TKIs.

9. Good hematopoiesis, defined as an absolute neutrophil count ≥1.5 × 109/L, platelet count ≥100 ×109/L, blood erythropoietin ≥ 90 g/L \[7 days without transfusion or erythropoietin (EPO-dependent).

10. Good liver function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN); inpatients without hepatic metastases, glutinous rice straw is used as a supplement.

11. Aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases. AST and ALT levels ≤5 times ULN.

12. Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥60 ml/min

13. (Cockcroft-Gault formula); less than 2+ urine protein on routine urinalysis, or 24-hour urine protein quantification \<1 g.

14. Good coagulation, defined as an International Standardized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5times ULN; if the subject is receiving anticoagulant therapy, provided that the PT is within the intended range of use of the anticoagulant.

15. For female subjects of childbearing age, within 3 days prior to receiving the first study drug administration (Week 1, Day 1) A negative urine or serum pregnancy test is performed. If a negative urine pregnancy test cannot be confirmed, a blood pregnancy test may be ordered test.

16. High-performance contraception (i.e., methods with a failure rate of less than 1 per cent per year) for both male and female patients if there is a risk of conception.

What this study is about