Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJun Zhang, MD, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Life expectancy ≥12 weeks
Males and females age ≥ 18 years
Disqualifiers
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study
Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment on this study
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
Mixed small cell and non-small cell lung cancer histology
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
44 Participants
are grouped into 1 trial groupGroup A: Participants receiving standard of care durvalumab
Trial outcomes
Primary outcomes
1
Grade 3 or higher adverse events (AE's)
CTCAE 5.0
Time frame
Up to 18 months2
Longitudinal changes in Microbiome
Metagenomic sequencing and taxonomic analysis
Time frame
Up to 18 months from study start3
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 startSecondary outcomes
1
Time-to-treatment withheld due to AEs
Time measured by days
Time frame
Up to 18 months from study start2
Time to immune-mediated AEs requiring systemic intervention
Time measured by days
Time frame
Up to 18 months from study start3
Progression free survival
Time measured by months
Time frame
Up to 36 months from study startSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Zhang, MD, PhD
Lead sponsor
University of Kansas Medical Center
Sponsor institution
Rhode Island Hospital
Collaborator
Source ClinicalTrials.gov