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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.

Phase 3RecruitingSun Yat-sen UniversityNCT05768490Data as of May 2026

Treatment: AlmonertinibThis 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.

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Extracted eligibility criteria

Biomarker criteria

Required: EGFR exon 19 deletion

Required: EGFR l858r

Disease stage

Metastatic disease required

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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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