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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
研究组 & 干预措施
early intervention group of brain radiotherapy
the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy
干预措施: brain radiotherapy (Radiation)
early intervention group of brain radiotherapy
the brain radiotherapy started within 1 month of almonertinib the brain radiotherapy here specifically refers to stereotactic radiotherapy
干预措施: Almonertinib (Drug)
late intervention group of brain radiotherapy
Brain radiotherapy was given within 3 months after brain progression during almonertinib treatment
干预措施: Almonertinib (Drug)
结局指标
主要结局
overall survival
时间窗: 3 years
The time from randomization to death from any cause.
次要结局
- intracranial progression free survival(2 years)
- progression free survival(2 years)
- intracranial objective response rate(6 months)
研究者
Li-kun Chen
Professor of Medicine
Sun Yat-sen University