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Trial Title:
Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases
NCT ID:
NCT05768490
Condition:
Brain Metastases
Radiotherapy
EGFR Activating Mutation
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
brain radiotherapy
Description:
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.
Arm group label:
early intervention group of brain radiotherapy
Intervention type:
Drug
Intervention name:
Almonertinib
Description:
almonertinib po 110mg QD
Arm group label:
early intervention group of brain radiotherapy
Arm group label:
late intervention group of brain radiotherapy
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun-Yat-Sen university
Address:
City:
Guangdong
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Likun Chen
Phone:
13798019964
Email:
chenlk@sysucc.org.cn
Start date:
March 15, 2023
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05768490
