NCT04643847Unknown2 期
Upfront Radiotherapy Combined With Almonertinib for Brain Metastasis in Non-small Cell Lung Cancer With EGFR Mutation: A Prospective Single-arm Phase II Trial
First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Central nerve system duration of response（CNS DOR）
研究概览
简要总结
Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study intends to assess the efficacy and safety of stereotactic radiosurgery with sequential almonertinib in treatment-naive EGFR-mutant NSCLC patients with brain metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or pathologically confirmed non-small-cell lung cancer (adenocarcinoma).
- •The presence of radiographically definite brain metastases and intracranial foci measurable according to the RANO-BM criteria.
- •The number of brain metastases ≤ 10, the volume of individual metastases ≤ 15 cc, the diameter of individual metastases ≤ 30 mm, the diameter of metastases in the brainstem ≤ 5 mm, distance of the foci from the optic nerve, or optic cross > 5 mm.
- •EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation).
- •Comply with the indications and drug instructions for first-line treatment with a third-generation EGFR-TKI.
- •Have not received systemic antineoplastic therapy, excluding neoadjuvant, adjuvant, or synchronous chemotherapy more than 6 months prior to enrollment.
- •Asymptomatic or mildly symptomatic brain metastases (e.g., headache, nausea, or seizures for which dexamethasone/analgesic/antiepileptic medication is effective and sustained at a steady dose for 3 days or more).
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status(PS) score ≤
- •Survival is expected to be ≥ 6 months.
- •Women must use contraception after surgical sterilization, after sterilization, or during and for three months after treatment.
- •With informed consent signed.
排除标准
- •Previous treatment with almonertinib or other EGFR-TKI.
- •Patients with symptomatic brain metastases resulting in neurological deficits (not including headaches, nausea, or controlled seizures).
- •Multiple sclerosis.
- •Pacemakers implanted in the body or metals that cannot be examined by MRI.
- •Allergy to magnetic resonance contrast agents.
- •Brain metastases requiring surgical decompression.
- •Meningeal metastases.
- •Previous radiotherapy or surgery for brain metastases.
- •Contraindications to radiotherapy for uncontrolled systemic lupus erythematosus, scleroderma, or other connective tissue diseases.
- •Other malignant neoplasms (except non-melanoma skin cancer and cervical cancer) within five years.
- •Any medical or non-medical reason that prevents the patient from continuing to participate in research.
- •It is expected that the patient will not be able to comply with the procedures, restrictions, and requirements of the study and the investigator determines that the patient is unfit to participate in the study.
- •Received studying drugs within 5 half-lives or 3 months, whichever is greater.
- •Currently receiving drugs or herbal supplements known to be potent inducers of Cytochrome P450 3A4(CYP3A4) or unable to be discontinued prior to receiving the first dose of study treatment) (at least 3 weeks prior).
- •The patient is taking any drug known to prolong the QT interval and cannot be discontinued until treatment with amitriptyline.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Stereotactic radiosurgery with Almonertinib
Experimental
110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions
干预措施: Almonertinib (Drug)
结局指标
主要结局
Central nerve system duration of response（CNS DOR）
时间窗: 1 year
Central nerve system duration of response assessed by RANO-BM criteria
次要结局
- overall survival (OS)(1 year)
- Intracranial response rate(RR）(1 year)
- Extracranial RR(1 year)
- Intracranial prgression-free survival(PFS)(1 year)
- quality of life(QoL) assessed by EORTC QLQ-C30(1 year)
- quality of life(QoL) assessed by EORTC QLQ-BN20(1 year)
- Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score(1 year)
研究者
研究点 (1)
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