Phase II Investigation of Use of CNS Active Pembrolizumab and Chemotherapy for Asymptomatic Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Disease Control Rate
研究概览
简要总结
The goal of this study is to evaluate whether providing Pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with NSCLC with untreated asymptomatic brain metastasis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases
- •NSLC lacks oncogenic driver mutations
- •Absence of new onset neurological symptoms
- •Presence of fewer than ten intracranial lesions
- •Each lesion measures three centimeters or less
- •Life expectancy of greater than three months
- •Adequate organ and marrow function
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Presence of oncogenic driver mutations
- •Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem
- •Known leptomeningeal involvement.
- •Midline shift
- •Serious non-healing wound, ulcer or bone fracture
- •Baseline inability to participate or complete neurocognitive testing
- •Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration
- •Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration
- •History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab
- •Clinically significant cardiovascular disease
- •Patients with uncontrolled intercurrent illness
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
干预措施: Pembrolizumab (Drug)
Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
干预措施: Nab paclitaxel (Drug)
Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
干预措施: Paclitaxel (Drug)
Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
干预措施: Pemetrexed (Drug)
Pembrolizumab with standard of care chemotherapy treatment
Patients will receive 200mg or 400mg of Pembrolizumab (standard of care dosing at the discretion of treating physician) over thirty minutes on day 1 every three or six weeks with standard of care chemotherapy treatment (carboplatin, pemetrexed, paclitaxel, nab-paclitaxel).
干预措施: Carboplatin (Drug)
结局指标
主要结局
Disease Control Rate
时间窗: 6 months (baseline to 6 months)
Intracranial benefit defined as stable disease, partial response, and complete response
次要结局
- Number of Participants With Overall Survival at 12-month Post-enrollment(12 months)
- Change in Extracranial Disease Control(12 months (6 months post-enrollment, 12 months post-enrollment))
- Change in Patient-reported Cognitive Functioning - Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)(12 months (Baseline and 12 months post enrollment))
- Change in Quality of Life - Functional Assessment of Cancer Therapy-Brain (FACT-Br)(12 months (Baseline and 12 months post enrollment))
- Change in Quality of Life - FACIT Fatigue Scale (FACIT-F)(12 months (Baseline and 12 months post enrollment))
- Change in Mild Cognitive Impairment (MoCA)(12 months (Baseline and 12 months post enrollment))
- Change in Performance Status(12 months (Baseline and 12 months post enrollment))
研究者
John L. Villano, MD, PhD
Principal Investigator
University of Kentucky