Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
研究概览
简要总结
This study looks at the side effects of chemotherapy and radiation (chemoradiation) followed by immunotherapy in patients with non-small cell lung cancer, with a particular focus on lung inflammation (pneumonitis). By collecting blood, stool and saliva samples, and data from lung function tests, researchers may be able to create a database of information about treatment and side effects in patients with non-small cell lung cancer who are receiving chemoradiation followed by immunotherapy. The information gained from this study may also help researchers find signs of problems with lung function earlier rather than later, since lung function is checked more often than routine care. This may improve how quickly these issues can be treated, and future patients may benefit from what is learned.
详细描述
PRIMARY OBJECTIVE:
I. To assess the association between the incidence of concurrent chemoradiation and subsequent immunotherapy-related adverse events, particularly radiation and immune-related pneumonitis, in patients with non-small cell lung cancer (NSCLC), and various clinicopathologic, radiologic, tumor, and demographic covariates of interest.
SECONDARY OBJECTIVES:
I. To correlate clinicopathologic, radiologic data and tumor characteristics with systemic longitudinal assessments of blood biomarkers for toxicity and response to therapy.
II. To monitor home spirometry and symptoms to identify early pneumonitis. III. To collect blood and microbiome samples from patients on immunotherapy and biopsy samples from toxicity sites at the time of toxicity to evaluate predictive markers for therapy related adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly-diagnosed NSCLC patients who will be undergoing concurrent chemotherapy and radiotherapy (XRT) followed by immune checkpoint inhibitors (CPI) therapy with durvalumab, as per the PACIFIC trial
- •Willing to undergo all treatment and evaluation at MD Anderson Cancer Center (MDACC)
- •Has access to a smartphone with the ability to transmit data via wireless connection or through their personal cellular plan
- •Able and willing to perform home spirometry (HS) weekly without absolute contraindications to performing spirometry
排除标准
- 未提供
研究组 & 干预措施
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Bronchoscopy with Bronchoalveolar Lavage (Procedure)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Computed Tomography (Procedure)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Diagnostic Laboratory Biomarker Analysis (Other)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Nasal Wash and Collection (Procedure)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Questionnaire Administration (Other)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Spirometry (Procedure)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Chemoradiotherapy (Other)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Immune Checkpoint Inhibitor (Drug)
Observational (biospecimen collection, standard treatment)
Patients undergo collection of blood, stool and saliva samples at baseline. Patients will also have a 6 minute walk and standard of care pulmonary function test at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 10 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and No BAL sample is collected at week 10. During the course of treatment, patients also complete routine tests and procedures to monitor for side effects per standard of care including CT within 4 weeks, lung function tests including home spirometry TIW from week 10-62, bronchoscopy and/or a nasal wash to check for viral infection. Patients also complete questionnaires about symptoms and quality of life QW for weeks 1-10, BIW during weeks 10-62.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC)
时间窗: Up to 12 months
All possible pneumonitis events will be adjudicated by an expert committee including Dr. Altan, Dr. Sheshadri, an expert infectious disease doctor, and an expert thoracic radiologist. Logistic regression will be used to assess the association between the development of pneumonitis and covariates of interest. Will also use logistic regression to model the association between the development of immune checkpoint inhibitor (CPI)-related pneumonitis and separately the development of radiation related pneumonitis. Secondary analyses of the primary endpoint will include assessing the time to the development of pneumonitis. Cox regression models will be fit in a similar manner to assess the association with the same covariates.
次要结局
- Financial hardship(Up to 12 months)
- Sleep quality(Up to 12 months)
- The M.D. Anderson Symptom Index (MDASI)(Up to 12 months)
- Dysbiosis(Up to 12 months)
- Use of home spirometry(Up to 12 months)
- Development of treatment-emergent immune related adverse events (irAE)(Up to 12 months)