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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04913311.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Ajay Sheshadri
Phone: 713-792-6238
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 bronchoalveolar lavage (BAL) 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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAjay Sheshadri
