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RECRUITING
NCT07505173
PHASE2

Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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 secondary endpoints such as PFS, ORR, disease control rate (DCR), overall survival (OS), adverse events (AE) evaluated per NCI-CTCAE v5.0 criteria, and neurocognitive function scores (MMSE/HVLT-R). By optimizing the combined mode of radiotherapy and targeted therapy, this study aims to provide a safer and more effective treatment option for such patients, balancing tumor control and quality of life protection.

Official title: Hippocampus-protective Synchronous Progressive Whole Brain Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in Advanced EGFR-Mutated Non-Small Cell Lung Cancer: A Prospective Phase II Multicenter Single-Arm Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-01-01

Completion Date

2029-01-01

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

OTHER

Hippocampal-Sparing Whole-Brain Radiotherapy + Simultaneous Integrated Boost to Brain Metastases + O

Hippocampal-Sparing Whole-Brain Radiotherapy + Simultaneous Integrated Boost to Brain Metastases + O

DRUG

Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-classic Mutated Lung Cancer

Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-classic Mutated Lung Cancer

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China