Phase I Trial of Feasibility and Safety of Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of patients who receive all fractions of radiotherapy as planned
研究概览
简要总结
Determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (immune checkpoint inhibitors) in adult patients with metastatic NSCLC with liver 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
- •Adult patients (≥18 years of age)
- •Histologically or cytologically confirmed NSCLC with liver metastases
- •Eligible for immune checkpoint inhibitors per treating medical oncologist
- •Disease must be measurable per RECIST criteria
- •ECOG Performance status of 0 - 2
- •Adequate organ function per protocol.
- •Allowable prior therapy includes adjuvant durvalumab, prior radiotherapy outside the upper abdomen.
- •Patients must be willing and able to sign an informed consent form.
- •Participants of childbearing potential willing to undergo pregnancy test and use contraception per Appendix.
排除标准
- •Liver tumor burden which cannot be targeted with SBRT per treating radiation oncologist
- •Presence of uncontrolled intercurrent illness or significant comorbidities precluding participation in a clinical study as determined by investigator
- •Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis).
- •Other invasive malignancy active within 1 years, excluding in situ cancers
- •Presence of psychiatric or substance abuse disorders that would interfere with compliance or safety
- •Has a known history of active Bacillus Tuberculosis (TB), Hepatitis B or Hepatitis C infection
- •Has received a live (active) vaccine within 30 days of enrollment.
- •Active autoimmune disease that has required systemic treatment in the past 1 years aside from hormone replacement therapy (ie. thyroxine, insulin, or physiologic corticosteroid replacement therapy)
- •Baseline corticosteroid use (>10 mg prednisone daily or equivalent) at study entry
- •Pregnancy or breast feeding
研究组 & 干预措施
Arm 1
This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC.
干预措施: Liver SBRT (Radiation)
Arm 1
This is an open-label, single-arm, single center clinical trial to evaluate the feasibility of liver SBRT (up to 4 metastases) during the first cycle of physician's choice ICI for NSCLC.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Percentage of patients who receive all fractions of radiotherapy as planned
时间窗: Up to 0.5 years after start of study treatment
Feasibility determination. Analyzed with descriptive statistics.
次要结局
- Proportion of patients who develop grade 3 or higher toxicity(Up to 1 year after start of study treatment)
- Progression-free survival(Time Frame: Up to 3 years after end of study treatment)
- Overall survival (OS)(Time Frame: Up to 3 years after end of study treatment)
- Proportion of patients with local control(Time Frame: Up to 3 years after end of study treatment)
研究者
Michael Green
Attending Physician, Radiation Oncology
VA Ann Arbor Healthcare System