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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05768490
Enrollment
232
Registered
2023-03-14
Start date
2023-03-15
Completion date
2029-12-31
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Radiotherapy, EGFR Activating Mutation

Brief 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.

Interventions

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
overall survival3 yearsThe time from randomization to death from any cause.

Secondary

MeasureTime frameDescription
progression free survival2 yearspatients were randomized from the time of observation of systemic disease progression or death from any cause
intracranial objective response rate6 monthsproportion of patients with complete or partial response of intracranial lesions
intracranial progression free survival2 yearspatients were randomized from the time of observation of intracranial disease progression or death from any cause

Countries

China

Contacts

Primary ContactLikun Chen, Ph.D
chenlk@sysucc.org.cn+8613798019964

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026