Predictors of Response to Immune Checkpoint Inhibitors in Non-small Cell and Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria
研究概览
简要总结
This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted through the nose or mouth to view the inside of the trachea, air passages, and lungs. Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid. Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that are more present in some cancers than others that will help determine which individuals have a greater or lesser chance of benefiting from immunotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.
SECONDARY OBJECTIVES:
I. To determine biomarkers that may be predictive of treatment related adverse events, specifically pneumonitis.
II. To further elucidate lung immunologic microenvironment by performing single cell analysis in addition to mass cytometry (Cytof) on cells of bronchoalveolar lavage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
- •Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI as any line of chemotherapy is acceptable) as deemed by individual's treating oncologist
- •Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study
排除标准
- •Coagulopathy with international normalized ratio (INR) > 2.0 or
- •Coagulopathy with platelets (Plt) < 10 k
- •Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- •Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications
- •Respiratory failure requiring greater than 6 Lpm supplemental oxygen (O2) by nasal cannula or mechanical ventilation within the past six weeks
- •Inability to perform informed consent due to any medical or psychiatric condition
研究组 & 干预措施
Bronchoscopy with bronchoalveolar lavage
Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes
干预措施: Bronchoscopy with Bronchoalveolar Lavage (Procedure)
Bronchoscopy with bronchoalveolar lavage
Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Biomarker response to immune checkpoint inhibitor therapy as measured by Response Evaluation Criteria in Solid Tumors version 1.1 criteria
时间窗: Up to 24 months
次要结局
未报告次要终点
研究者
Fabien Maldonado
Principal Investigator
Vanderbilt-Ingram Cancer Center