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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-01136 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0889 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
IV. To determine the effect of concurrent chemotherapy followed by immunotherapy on sleep quality.
V. To determine the impact of sleep disturbance on gut and oral dysbiosis. VI. To characterize longitudinal changes in fatigue and financial toxicity with concurrent chemotherapy followed by immunotherapy.
OUTLINE:
Patients undergo collection of blood, stool and saliva samples at baseline. Patients receive standard of care treatment consisting of concurrent chemoradiation from baseline up to week 62 and immune checkpoint inhibitors from week 10-62. Patients also undergo the collection of blood, stool, saliva and samples 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 computed tomography (CT) within 4 weeks, lung function tests including home spirometry three times a week (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 once a week (QW) for weeks 1-9, twice a week (BIW) during weeks 5-54, and once a month until week 62.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of pneumonitis during chemoradiotherapy and immunotherapy for locally advanced non-small cell lung cancer (NSCLC) | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The M.D. Anderson Symptom Index (MDASI) | Monitor home spirometry and symptoms to identify early pneumonitis. The MDASI is a brief (less than 5 minutes), psychometrically validated, multi-symptom assessment tool developed for use with cancer patients who are either undergoing or have completed cancer therapies. MDASI-immunotherapy will be administered weekly for the first 9 weeks of study, every two weeks from week 10 to week 54, and monthly until the end of study (week 62). If MDASI increases by 1, patients will be contacted to be evaluated for the possible development of pneumonitis, infection, or disease progression. |
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Inclusion Criteria:
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Patients with newly-diagnosed NSCLC (with a particular focus on lung inflammation) scheduled to undergo chemoradiation followed by immunotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Sheshadri | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Blood, stool, saliva, bronchoalveolar lavage and nasal wash sample
| Bronchoscopy with Bronchoalveolar Lavage | Procedure | Undergo bronchoscopy with BAL |
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| Chemoradiotherapy | Other | Undergo concurrent chemoradiation per standard of care |
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| Computed Tomography | Procedure | Undergo computed tomography scan |
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| Diagnostic Laboratory Biomarker Analysis | Other | Correlative studies |
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| Immune Checkpoint Inhibitor | Drug | Receive CPI per standard of care |
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| Nasal Wash and Collection | Procedure | Undergo nasal wash |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Spirometry | Procedure | Under lung spirometry tests |
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| Up to 12 months |
| Use of home spirometry | Home spirometry will measured forced lung function values such as vital capacity which will be monitored over time in study participants. | Up to 12 months |
| Development of treatment-emergent immune related adverse events (irAE) | The development of treatment-emergent irAE overall and separately by type of AE will be summarized by the method of Kaplan and Meier. For AEs with enough events, may use Cox regression models to model the association with covariates of interest, including blood biomarkers. | Up to 12 months |
| Sleep quality | Will assess the association between chemotherapy followed by immunotherapy and sleep quality by using the Pittsburgh Quality Sleep Index (PQSI). | Up to 12 months |
| Financial hardship | Will assess the association between financial hardship as measured by changes in the Economic Strain and Resilience in Cancer survey and covariates of interest using linear regression. | Up to 12 months |
| Dysbiosis | Will be defined as an abnormal microbiome either measured orally or from the gut bacteria in the stool. | Up to 12 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018893 | Bronchoalveolar Lavage |
| D001992 | Bronchoalveolar Lavage Fluid |
| D059248 | Chemoradiotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| D055556 | Nasal Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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