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 (Jun 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
Treatments studied
Targeted therapy
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Disease stage
Metastatic disease required
Demographics
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.
Frequently asked questions
Is NCT05768490 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify