OncoMatch/Clinical Trials/NCT05768490
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
Is NCT05768490 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Almonertinib for brain metastases.
Treatment: Almonertinib — This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: EGFR inhibitor
Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past
Cannot have received: EGFR inhibitor
Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment
Cannot have received: systemic anti-tumor therapy
Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment
Cannot have received: brain radiotherapy
The subjects had received brain radiotherapy before enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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