Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
NCT ID: NCT04913311
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-01-21
2027-02-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with BAL
Chemoradiotherapy
Undergo concurrent chemoradiation per standard of care
Computed Tomography
Undergo computed tomography scan
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Immune Checkpoint Inhibitor
Receive CPI per standard of care
Nasal Wash and Collection
Undergo nasal wash
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Spirometry
Under lung spirometry tests
Interventions
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Biospecimen Collection
Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with BAL
Chemoradiotherapy
Undergo concurrent chemoradiation per standard of care
Computed Tomography
Undergo computed tomography scan
Diagnostic Laboratory Biomarker Analysis
Correlative studies
Immune Checkpoint Inhibitor
Receive CPI per standard of care
Nasal Wash and Collection
Undergo nasal wash
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Spirometry
Under lung spirometry tests
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ajay Sheshadri
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-01136
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0889
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0889
Identifier Type: -
Identifier Source: org_study_id
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