RecruitingPhase 3NCT05768490

Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases

A Prospective, Multicenter, Randomized, Controlled Clinical Study of Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases


Sponsor

Sun Yat-sen University

Enrollment

232 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares giving brain radiation therapy early versus later in patients with EGFR-mutant non-small cell lung cancer (NSCLC) that has spread to a small number of areas in the brain. All patients will receive a targeted drug called almonertinib. **You may be eligible if...** - You have been diagnosed with NSCLC confirmed by biopsy - Your tumor has an EGFR mutation (specifically exon 19 deletion or L858R) - You have fewer than 5 brain metastases visible on MRI, with the tumors at least 3mm from the optic nerve and brainstem - You have not previously received any treatment for your brain metastases or any EGFR-targeting drugs **You may NOT be eligible if...** - You have already been treated for brain metastases - You have already received EGFR-targeted therapy (such as osimertinib or erlotinib) - You have more than 4 brain tumors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONbrain 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.

DRUGAlmonertinib

almonertinib po 110mg QD


Locations(1)

Sun-Yat-Sen university

Guangdong, Guangzhou, China

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NCT05768490


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