NCT03769103进行中（未招募）2 期
Open Label, Multicenter, Phase II Study of Patients With Treatment Naïve Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases Randomized to Stereotactic Radiosurgery (SRS) and Osimertinib or Osimertinib Alone
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Intracranial progression free survival
研究概览
简要总结
This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent by patient or legally acceptable representative
- •Meets the criteria in the approved regulatory indication for first line treatment with osimertinib and agree to the restrictions, monitoring, and dose-adjustment criteria stipulated in the associated product label
- •Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)
- •No prior systemic therapy except neoadjuvant, adjuvant or concurrent chemotherapy given greater than 3 months prior to enrollment on study
- •Asymptomatic or minimally symptomatic brain metastases (ie. Headache, nausea, or seizure responsive to dexamethasone/analgesic/antiepileptic on stable doses of medications for a minimum of 3 days)
- •Brain metastases must meet the following criteria on a diagnostic MRI: at least one lesion can be classified as measurable disease per RANO-BM, ≤ 10 brain or brainstem metastases, ≤ 30 mm and brainstem metastases must be ≤ 5 mm, metastases > 5 mm from the optic nerve or chiasm
- •ECOG performance status 0-2
- •Life expectancy > 6 months
- •Willing to abstain from sexual activity or willing to use double-barrier method during sexual intercourse
排除标准
- •Previous treatment with osimertinib, or any other EGFR TKI
- •Patient with symptomatic brain metastases causing any neurologic deficit (not including headache, nausea, or medically controlled seizure)
- •Multiple sclerosis
- •Pacemaker or MRI-incompatible metal in the body
- •Allergy to gadolinium MRI contrast
- •Brain metastasis requiring surgery for decompression
- •Leptomeningeal disease
- •Previous cranial RT, or surgery for brain metastases
- •Uncontrolled systemic lupus erythematosis, scleroderma or other connective tissue disorders considered a contraindication for radiotherapy
- •Active cancer from another anatomical site within 5 years (non-melanomatous skin and cervical cancers permitted)
- •Any medical or non-medical issue that would render patient unable to reliably complete regular QOL and neurocognitive assessments
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- •Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
- •Patients with symptomatic CNS metastases who are neurologically unstable
- •Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
- •Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib
- •Pregnant or breastfeeding
研究组 & 干预措施
SRS + Osimertinib
Active Comparator
Stereotactic radiotherapy will be delivered in 1-5 fractions to each brain metastases according to the volume and location of the metastases and clinician discretion. Osimertinib will start 1-7 days post radiotherapy.
干预措施: Osimertinib (Drug)
SRS + Osimertinib
Active Comparator
Stereotactic radiotherapy will be delivered in 1-5 fractions to each brain metastases according to the volume and location of the metastases and clinician discretion. Osimertinib will start 1-7 days post radiotherapy.
干预措施: Stereotactic radiotherapy (Radiation)
Osimertinib alone
Experimental
Osimertinib 80mg PO daily
干预措施: Osimertinib (Drug)
结局指标
主要结局
Intracranial progression free survival
时间窗: 1 year
Absence of progressive brain metastases according to the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM criteria)
次要结局
- Intracranial overall response rate(2 years)
- Time to distant progression(2 years)
- Time to whole brain radiotherapy (WBRT)(2 years)
- Exposure to osimertinib(2 years)
- Overall survival(2 years)
- Quality of life(2 years)
- Time to stereotactic radiosurgery (SRS)(2 years)
- Rate of radionecrosis(2 years)
- Neurocognitive function(2 years)
研究者
研究点 (3)
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