This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.
Study Type
OBSERVATIONAL
Enrollment
44
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
RECRUITINGRhode Island Hospital, Brown University
Providence, Rhode Island, United States
NOT_YET_RECRUITINGGrade 3 or higher adverse events (AE's)
CTCAE 5.0
Time frame: Up to 18 months
Longitudinal changes in Microbiome
Metagenomic sequencing and taxonomic analysis
Time frame: Up to 18 months from study start
Longitudinal changes in bacterial metabolic pathway
Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping
Time frame: Up to 18 months from study start
Time-to-treatment withheld due to AEs
Time measured by days
Time frame: Up to 18 months from study start
Time to immune-mediated AEs requiring systemic intervention
Time measured by days
Time frame: Up to 18 months from study start
Progression free survival
Time measured by months
Time frame: Up to 36 months from study start
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