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

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 ar

Trial Details

NCT ID

NCT07505173

Phase

PHASE2

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

RECRUITING

Cancer Type

Lung Cancer

Interventions

Hippocampal-Sparing Whole-Brain Radiotherapy + Simultaneous Integrated Boost to Brain Metastases + O
Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-classic Mutated Lung Cancer

Locations (sample)

Tianjin, China|39.14222,117.17667

Key Eligibility 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 dele…
Brain metastasis confirmed by contrast-enhanced cranial CT/MRI; the number of brain metastatic lesions requiring local dose escalation is 1-10, wit…

For full eligibility, visit ClinicalTrials.gov.

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