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(Slides)

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A prospective study called MicroDurva is being conducted to investigate the role of the microbiome in predicting adverse events (AEs) in post-concurrent chemoradiation (CCRT) non-small cell lung cancer (NSCLC) patients receiving durvalumab treatment. The PACIFIC trial has shown that durvalumab maintenance therapy following CCRT provides a survival benefit for stage III unresectable NSCLC patients. However, about 30% of patients experienced grade 3/4 AEs, and 25% experienced any-grade immune-related AEs (irAEs) with durvalumab. Previous research has suggested that the microbiome may be correlated with treatment response and irAEs in immunotherapy using immune checkpoint inhibitors (ICIs). This study aims to explore whether the microbiome from different body sites (nasal, buccal, and gut) can predict AEs from durvalumab in post-CCRT NSCLC patients.<br /><br />The study will involve eligible participants with locally advanced unresectable NSCLC who have achieved stable disease after platinum-based CCRT. Participants will receive durvalumab intravenously every 4 weeks for up to 12 months. Baseline microbiome specimens (nasal and buccal swabs, and stool sample) will be collected before durvalumab treatment, along with other baseline measurements and a questionnaire documenting factors that may impact the microbiome. Microbiome specimens, blood tests, and questionnaires will be collected every 10-12 weeks during treatment. Additional collections will occur when durvalumab is withheld due to AEs or when AEs reduce to grade 1 or less. Participants will be followed for 24 months after the end of treatment to monitor AEs and survival.<br /><br />The primary objective of the study is to compare the microbiomes from different sources and determine if they correlate with AEs, especially grade 3/4 AEs, from durvalumab treatment. Secondary objectives include evaluating correlations with other biomarkers and therapeutic benefits like progression-free survival. The study is currently open at the University of Kansas Comprehensive Cancer Center and the Lifespan Cancer Institute of Brown University.<br /><br />The study is funded by AstraZeneca, and the lead researcher, Dr. Jun Zhang, has served as a scientific advisor/consultant and received research funding/support from multiple pharmaceutical companies. Previous published work by the researchers has shown correlations between the gut microbiome and immunotherapy response and irAEs in solid tumors, as well as its predictive abilities for progression-free survival and response to ICIs in metastatic NSCLC patients.

Asset Subtitle

Jun Zhang

Meta Tag

Speaker Jun Zhang

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

MicroDurva

microbiome

adverse events

post-concurrent chemoradiation

non-small cell lung cancer

durvalumab treatment

PACIFIC trial

immune-related AEs

immunotherapy

immune checkpoint inhibitors