NCT04650490撤回2 期
A Randomized, Phase II Trial of SRS Timing With Immune Checkpoint Inhibition in Patients With Untreated Brain Metastases From Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Intracranial progression free-survival
研究概览
简要总结
This trial is a randomized, 2-arm, phase II study to determine the effect, if any, of the timing of stereotactic radiosurgery (SRS) relative to immune checkpoint inhibitor (IO) therapy in patients with non-small cell lung cancer (NSCLC) that has spread (metastasized) to the brain.
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
- •Patients must have 1 to 15 newly diagnosed brain metastases, ≤5 cm in the largest dimension, with at least one metastasis measuring ≥0.3 cm.
- •Primary tumor histology must be one confirmed as one of the following:
- •Squamous NSCLC
- •Adenocarcinoma NSCLC
- •Not otherwise specified NSCLC
- •Patient must have an MRI of the brain within 4 weeks (28 days) of signing the study consent.
- •Patient must be planned for immunotherapy treatment as their next systemic therapy, including monotherapy or in combination with chemotherapy.
- •Patients previously treated with a tyrosine kinase inhibitor (TKI) may be eligible, if a second line (or later) immunotherapy regimen is planned.
- •Patients must be asymptomatic or minimally symptomatic, requiring the equivalent of ≤2 mg dexamethasone/day for at least 7 days prior to enrollment.
- •Female and male subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in the Duke Contraception Policy.
- •Age ≥18 years of age at the time of entry into the study.
- •Karnofsky Performance Score (KPS) ≥70.
排除标准
- •Patients on the equivalent of >2 mg of dexamethasone (or prednisone/steroid equivalent) daily ≤ 7 days before receiving study treatment.
- •Patients who have previously received whole brain radiation therapy (WBRT).
- •Patients must not have ever received immunotherapy in the stage IV setting. Prior immune therapy as part of treatment for stage I-III disease is allowed after an interval of >6 months has passed from the completion of that therapy.
- •Patients with leptomeningeal carcinomatosis. However, patients with discrete dural-based lesions may be eligible at the discretion of the treating radiation oncologist.
- •Females who are pregnant or breastfeeding.
- •Patients with an impending, life-threatening cerebral hemorrhage or herniation, based on the assessment from a brain MRI of the study neurosurgeons or their designee.
- •Patients with severe, active co-morbidity, defined as follows:
- •Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
- •Patients with known immunosuppressive disease or known uncontrolled human immunodeficiency virus infection
- •Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)
- •Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used.
- •Patients with prior, unrelated malignancy requiring current active treatment in the last 3 years with the exception of cervical carcinoma in situ, prostate cancer at stage I-III and adequately treated basal cell or squamous cell carcinoma of the skin
- •Patients with a known history of hypersensitivity to the physician's choice of immune checkpoint inhibitor, or any components of the inhibitor.
- •Patients who have any contraindications to immunotherapy.
- •Patients with active autoimmune disease requiring systemic immunomodulatory treatment, including steroid of >10 mg prednisone daily or equivalent, within the past 3 months.
研究组 & 干预措施
Immediate SRS followed by IO
Experimental
Participants will receive SRS followed by physician's choice of standard of care immunotherapy, given at the FDA-approved dose within 14 days of SRS.
干预措施: Stereotactic Radiosurgery (Radiation)
Immediate SRS followed by IO
Experimental
Participants will receive SRS followed by physician's choice of standard of care immunotherapy, given at the FDA-approved dose within 14 days of SRS.
干预措施: Immunotherapy (Drug)
Immediate IO followed by SRS
Experimental
Participants will receive physician's choice of immunotherapy, given at the FDA-approved dose followed by SRS, if deemed appropriate, at the time of intracranial progression.
干预措施: Stereotactic Radiosurgery (Radiation)
Immediate IO followed by SRS
Experimental
Participants will receive physician's choice of immunotherapy, given at the FDA-approved dose followed by SRS, if deemed appropriate, at the time of intracranial progression.
干预措施: Immunotherapy (Drug)
结局指标
主要结局
Intracranial progression free-survival
时间窗: from randomization through study completion, an average of 3 years
Defined as defined as time to intracranial progression from randomization measured by by RANO-BM criteria for radiographic progression on contrast-enhanced brain MRI
次要结局
- Assess neurocognitive outcome in each arm by the Controlled Oral Word Association test(1 year)
- Assess neurocognitive outcome in each arm by the Hopkins Verbal Learning Test - Revised(1 year)
- Assess quality of life in each arm by the Functional Assessment of Cancer Therapy - Brain questionnaire(1 year)
- Assess neurocognitive outcome in each arm by the Trail Making Test Parts A and B(1 year)
研究者
研究点 (1)
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