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

ConditionsBrain MetastasesRadiotherapyEGFR Activating Mutation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically or cytologically confirmed non-small cell lung cancer;

Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI, the number of intracranial parenchymal metastases was less than 5, and the lesions were 3mm away from the optic nerve and brainstem; There must be at least one measurable lesion with a diameter of 5mm or more in the brain.

EGFR sensitivity mutation (exon19del or exon21 L858R);

Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: early intervention group of brain radiotherapyExperimental treatment 2 interventions
Group B: late intervention group of brain radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

The time from randomization to death from any cause.

Time frame
3 years

Secondary outcomes

1

intracranial progression free survival

patients were randomized from the time of observation of intracranial disease progression or death from any cause

Time frame
2 years
2

progression free survival

patients were randomized from the time of observation of systemic disease progression or death from any cause

Time frame
2 years
3

intracranial objective response rate

proportion of patients with complete or partial response of intracranial lesions

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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