Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Microdurva
Microdurva
Sponsor study identifier
observational
44
1 country
2
Study Start
April 12, 2021
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 17, 2020
Actual (reported)December 23, 2020
Actual (reported)April 12, 2021
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Grade 3 or higher adverse events (AE's)
CTCAE 5.0
Up to 18 months
Longitudinal changes in Microbiome
Metagenomic sequencing and taxonomic analysis
Up to 18 months from study start
Longitudinal changes in bacterial metabolic pathway
Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping
Up to 18 months from study start
Time-to-treatment withheld due to AEs
Up to 18 months from study start
Time to immune-mediated AEs requiring systemic intervention
Up to 18 months from study start
Progression free survival
Up to 36 months from study start
Prior to receiving treatment participants will have samples taken from three different sources to test the microbiome bacteria to determine if it will help predict toxicity to the treatment
Participants must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease. Participants must have not progressed following definitive, platinum-based, concurrent chemoradiation therapy.
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205, United States
Rhode Island Hospital, Brown University
Providence, Rhode Island, 02905, United States
Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.
Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.
nasal and buccal swabs, and stool
Jun Zhang, MD, PhD
The University of Kansas Cancer Center
First Submitted
December 17, 2020
First Posted
December 23, 2020
Study Start
April 12, 2021
Actual (reported)Primary Completion
December 2025
Estimated (date passed)A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2024
Record last verified: 2024-05
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