Observational Study on Microbiome and Durvalumab Toxicity in NSCLC
This observational study is looking at patients with Stage III non-small cell lung cancer (NSCLC) who are receiving durvalumab after chemoradiation. Researchers want to see if changes in your microbiome (the collection of tiny organisms living in and on your body) can help predict if you will experience severe side effects (Grade 3 or higher adverse events) from durvalumab. They will be tracking these side effects and changes in your microbiome and its metabolic pathways for up to 18 months. You may be able to join if you are 18 or older, can understand the study, and are willing to follow the study plan. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study that plans to include 44 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 18 months from the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04680377
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
Recruiting
Not specifiedAges 18+ObservationalJun Zhang, MD, PhDInvestigator-initiated
~44 participants
Updated 2024-05-08 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade 3 or higher adverse events (AE's)
Measured over Up to 18 months
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesKansas1
Rhode Island1
Study leadership
- Jun Zhang, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Kansas Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Allowable type and amount of prior therapy:
Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1
Body weight \>30 kg (66.14 lbs)
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
Adequate organ function based on laboratory results
Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for the time specified following completion of therapy
Any grade pneumonitis from prior chemoradiation therapy
Active infection
Recent major surgery within 28 days prior to the first dose of study therapy
Active or prior documented autoimmune or inflammatory disorders
History of primary immunodeficiency
History of another primary malignancy
History of allogenic organ transplantation/organ transplant that requires therapeutic immunosuppression
History of leptomeningeal carcinomatosis
Participants with active ventricular arrhythmia requiring medication
Uncontrolled intercurrent illness
Participants who have progressed following definitive, platinum-based, concurrent chemoradiation therapy
Known allergy or hypersensitivity to durvalumab or any of durvalumab's excipients
Psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
Exclusion
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
Participants who receive sequential chemoradiation therapy for locally advanced NSCLC
Participants with locally advanced NSCLC who have progressed whilst definitive platinum based, concurrent chemoradiation therapy
Receipt of any investigational drug within 4 weeks prior to the first dose of durvalumab; and in the case of monoclonal antibodies (not immunotherapy) 6 weeks prior to the first dose of durvalumab
Participants who have received prior anti-programmed death (PD)-1, anti- programmed death ligand (PD-L)1 or anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4
Participants who have received prior immunotherapy
Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Participants, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of IP
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
What this trial measures
- Grade 3 or higher adverse events (AE's)Up to 18 months
CTCAE 5.0
- Longitudinal changes in MicrobiomeUp to 18 months from study start
Metagenomic sequencing and taxonomic analysis
- Longitudinal changes in bacterial metabolic pathwayUp to 18 months from study start
Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping