Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer

Arms (1)

1. label

   Observational (biospecimen collection, standard treatment)

   description

   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.

   interventionNames

   1. Procedure: Biospecimen Collection
   2. Procedure: Bronchoscopy with Bronchoalveolar Lavage
   3. Other: Chemoradiotherapy
   4. Procedure: Computed Tomography
   5. Other: Diagnostic Laboratory Biomarker Analysis
   6. Drug: Immune Checkpoint Inhibitor
   7. Procedure: Nasal Wash and Collection
   8. Other: Quality-of-Life Assessment
   9. Other: Questionnaire Administration
   10. Procedure: Spirometry

Primary outcomes (1)