2023 World Conference on Lung Cancer (Posters)-EP08.03. MicroDurva: A Prospective Study to Investigate the Role of Microbiome in Predicting the AEs from Durvalumab in Post-CCRT NSCLC Patients

EP08.03. MicroDurva: A Prospective Study to Investigate the Role of Microbiome in Predicting the AEs from Durvalumab in Post-CCRT NSCLC Patients - PDF(Abstract)

Back to course

Pdf Summary

The session at the WCLC 2023 conference titled "Local-Regional Non-small Cell Lung Cancer - Novel Therapies and Trials" presented a study called MicroDurva. The study aims to investigate the role of the microbiome in predicting adverse events (AEs) from the immunotherapy drug durvalumab in post-concurrent chemoradiation therapy (CCRT) non-small cell lung cancer (NSCLC) patients. The PACIFIC trial showed that durvalumab maintenance after CCRT has a survival benefit, but it also resulted in AEs in some patients. Given the correlation between the microbiome and treatment response and AE occurrence in immunotherapy, the MicroDurva study seeks to explore whether the microbiome from different body sites can predict AEs from durvalumab in NSCLC patients.<br /><br />The study will enroll participants who have locally advanced unresectable NSCLC and have achieved stable disease after CCRT. These participants will receive durvalumab intravenously every 4 weeks for up to 12 months. Before treatment, baseline microbiome specimens (nasal and buccal swabs, and stool sample) will be collected, along with other biomarkers and a questionnaire regarding factors that may impact the microbiome. Subsequent collections of microbiome specimens, biomarkers, and questionnaires will be done every 10-12 weeks. Additional collections will occur when durvalumab is withheld due to AEs or when AEs reduce. Metagenomic analyses will be performed on the microbiome specimens.<br /><br />The primary objective of the study is to compare microbiomes from different sources (nasal, buccal, and gut) and determine if they correlate with AEs, especially grade 3/4 AEs, from durvalumab treatment. Secondary objectives include assessing correlations between microbiomes and other biomarkers, as well as therapeutic benefits like progression-free survival. The study is ongoing at the University of Kansas Comprehensive Cancer Center and the Lifespan Cancer Institute of Brown University, with 25% enrollment achieved so far.<br /><br />In summary, the MicroDurva study is investigating the link between the microbiome and AEs from durvalumab treatment in post-CCRT NSCLC patients. By analyzing microbiome specimens from different body sites, the study aims to identify potential predictors of AEs and explore their correlation with therapeutic benefits.

Asset Subtitle

Jun Zhang

Meta Tag

Speaker Jun Zhang

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

WCLC 2023 conference

Local-Regional Non-small Cell Lung Cancer

Novel Therapies and Trials

MicroDurva study

microbiome

adverse events

durvalumab

post-concurrent chemoradiation therapy

non-small cell lung cancer

PACIFIC trial