Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. Determine if progression-free survival at 24 weeks with this treatment combination is improved compared to historical controls who received immunotherapy without radiation therapy.
SECONDARY OBJECTIVES:
I. Assess acute (0-6 months) and late (> 6 months) grade 3-5 toxicity. II. Assess overall survival. III. Correlate circulating tumor deoxyribonucleic acid (DNA) (ratio of post-radiation therapy [RT] to pre-RT level) with radiographic response.
IV. Correlate immune markers in peripheral blood with radiographic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Has stage IV non-small cell lung cancer, or initially stage I-III disease with distant metastatic recurrence
- •Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks (refer to section 4.2.1)
- •Has had restaging imaging after initiation of immunotherapy, at least 4 weeks after pre-immunotherapy baseline imaging. CT or PET/CT of at least chest/upper abdomen must be performed within 4 weeks prior to registration. For patients with history of brain metastases, brain MRI or CT is required within 4 weeks of registration; for other patients brain MRI or CT is required within 12 weeks of registration. Diagnostic PET/CT performed as part of radiation simulation can be used as the restaging imaging.
- •Most recent imaging shows measurable disease as defined by RECIST 1.1
- •Evaluation by a Stanford medical oncologist must show:
- •The patient is expected to continue on immunotherapy for at least three more months
- •Imaging must show response, stable disease, or modest progression
- •If there is modest progression, the patient must be clinically stable in terms of performance status and overall disease-related symptoms
- •Has at least one extracranial tumor safely treatable with radical-dose radiation therapy and that has not been previously treated with radiation
- •ECOG performance status 0-2
- •Has the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Untreated brain metastases, if not planned to be treated in this course of radiation therapy
- •Pregnancy or women of childbearing potential not willing/able to use contraception during protocol treatment
研究组 & 干预措施
Immunotherapy plus Image-guided Radiation Therapy
Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy.
干预措施: Image-guided Radiation Therapy (Radiation)
Immunotherapy plus Image-guided Radiation Therapy
Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy.
干预措施: Immunotherapy (physician's choice for standard of care immunotherapy) (Drug)
Immunotherapy Alone (Regular Medical Care)
Patients who decline to undergo radiation therapy will continue their prior treatment with the treating physician's choice of regular medical care immunotherapy.
干预措施: Immunotherapy (physician's choice for standard of care immunotherapy) (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: 24 weeks from study entry
Defined as percentage of participants without disease progression or death at 24 weeks from date of study entry, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions Overall Response (OR): CR + PR
次要结局
- Change in Circulating Tumor Deoxyribonucleic Acid Levels as Measured Using CAncer Personalized Profiling by Deep Sequencing(Baseline (pre-treatment))
- Change in Immune Marker Levels as Measured From Peripheral Blood Using Flow Cytometry Performed by the Human Immune Monitoring Core at Stanford University(Pre-radiation (up to 14 days before RT) and post-radiation (up to 14 days after completion of RT))
- Number of Participants With Acute (0-6 Months) and Late (> 6 Months) Grade 3-5 Toxicity(Up to 4 years after study entry)
- Overall Survival(Time from study entry to death, assessed up to 4 years after study entry)
研究者
Michael Francis Gensheimer
Clinical Associate Professor, Radiation Oncology - Radiation Therapy
Stanford University