Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy in Patients With Non-small Cell Lung Cancer
Predictive Biomarkers for Pneumonitis After Chemoradiotherapy and Immunotherapy
M.D. Anderson Cancer Center
150 participants
Jan 21, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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
Interventions
Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
Undergo bronchoscopy with BAL
Undergo concurrent chemoradiation per standard of care
Undergo computed tomography scan
Correlative studies
Receive CPI per standard of care
Undergo nasal wash
Ancillary studies
Ancillary studies
Under lung spirometry tests
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04913311