Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metast
This is a single-arm, multicenter, open-label, phase Ⅱ exploratory clinical study, which plans to enroll 74 treatment-naive patients with EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and symptomatic brain metastases from non-small cell lung cancer (NSCLC). The primary objective is to evaluate the
| Condition(s) | Naive Advanced Non-small Cell Lung Cancer With EGFR-sensitive Mutations (EGFR Exon 19 Deletion and Exon 21 L858R Mutation) and Symptomatic Brain Metastases |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single-arm, multicenter, open-label, phase Ⅱ exploratory clinical study, which plans to enroll 74 treatment-naive patients with EGFR-sensitive mutations (exon 19 deletion, exon 21 L858R mutation) and symptomatic brain metastases from non-small cell lung cancer (NSCLC). The primary objective is to evaluate the intracranial progression-free survival (iPFS) of hippocampal-sparing whole-brain radiotherapy (PTV: 20Gy/10 fractions) combined with simultaneous integrated boost to brain metastases (PGTV: 40Gy/10 fractions) plus osimertinib (80mg orally once daily). The secondary objectives are to assess efficacy indicators including overall progression-free survival (PFS), intracranial/systemic objective response rate (ORR), as well as safety. The primary endpoint is iPFS, supplemented by |
| Who can participate | Inclusion Criteria: * Signed a written informed consent form prior to enrollment; * Aged 18-75 years; * Histopathologically confirmed non-small cell lung adenocarcinoma (NSCLC); EGFR gene test confirmed EGFR sensitive mutations, including exon 19 deletion (19del) and exon 21 L858R mutation (verified and confirmed by investigators at the respective study centers); * Brain metastasis confirmed by contrast-enhanced cranial CT/MRI; the number of brain metastatic lesions requiring local dose escalation is 1-10, with at least one measurable intracranial lesion having a diameter ≥10 mm; the distance between metastatic lesions and important cerebral functional areas meets radiotherapy-related requirements; at least one measurable lesion (per RECIST v1.1 criteria) confirmed by contrast-enhanced ext |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Tianjin, China |
| Start date | 2026-01-01 |
| NCT ID | NCT07505173 |
| Official listing | https://clinicaltrials.gov/study/NCT07505173 |