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

Sponsor
Sun Yat-sen University
Study ID
NCT05768490
Phase
PHASE3
Status
Recruiting
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Conditions

  • Brain Metastases
  • EGFR Activating Mutation
  • Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • brain radiotherapy — RADIATION
    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.
  • Almonertinib — DRUG
    almonertinib po 110mg QD

Study Details

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.

Key Dates

First listed
Mar 14, 2023
Start date
Mar 15, 2023
Status verified
Mar 2023
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
232 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: early intervention group of brain radiotherapy
    the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy
  • Active Comparator: late intervention group of brain radiotherapy
    Brain radiotherapy was given within 3 months after brain progression during almonertinib treatment

Primary Outcome Measure

overall survival [ Time Frame: 3 years ]

Central Contacts

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