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Recruiting NCT05768490

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

Phase III Interventional Brain Metastases Radiotherapy EGFR Activating Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: brain radiotherapy, Almonertinib.
Who it may be relevant to
Registry conditions: Brain Metastases, Radiotherapy, EGFR Activating Mutation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation 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.
  • Drug Almonertinib
    almonertinib po 110mg QD

Primary outcome measures

  • overall survival [Time frame: 3 years]
Secondary outcome measures (3)
  • intracranial progression free survival [Time frame: 2 years]
  • progression free survival [Time frame: 2 years]
  • intracranial objective response rate [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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;
  • Age 18-75;

Inclusion criteria

  • A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
  • The subjects had received brain radiotherapy before enrollment;
  • Patients whose lung lesions were surgically evaluated as resectable were not included if there was no metastasis in other parts of the body;
  • Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment;
  • Prior patients with interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease with idiopathic pulmonary fibrosis found on CT scan at baseline;
  • Pregnant and lactating patients;
  • MRI contraindicated patients;
  • Patients who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery that interferes with absorption, or have active digestive tract ulcers;
  • The researchers judged that brain radiotherapy could not be received because of other head and facial diseases;
  • Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun-Yat-Sen university — Guangdong

Identifiers

NCT: NCT05768490 · B2022-428-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗