ClinicalTrials.Veeva

Menu

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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Enrolling
Phase 3

Conditions

Brain Metastases
EGFR Activating Mutation
Radiotherapy

Treatments

Radiation: brain radiotherapy
Drug: Almonertinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05768490
B2022-428-01

Details and patient eligibility

About

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.

Enrollment

232 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Central trial contact

Likun Chen, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems