NSCLC, Stage IIIMicrodurvaNCT04680377
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients
An observational study of NSCLC, Stage III and Locally Advanced Lung Carcinoma, run by Jun Zhang, MD, PhD at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage III, Locally Advanced Lung Carcinoma
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2021to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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:
- Participants must have received two or more cycles of platinum-based chemotherapy (containing etoposide, vinblastine, vinorelbine, a taxane [paclitaxel or docetaxel], or pemetrexed) concurrently with definitive radiation therapy (54-66 Gy)
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- 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
Who cannot join
- 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
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- 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
- Any unresolved toxicity CTCAE ≥ Grade 2 from the prior chemoradiation / anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Not yet recruiting
Rhode Island Hospital, Brown University
Providence, Rhode Island, 02905
Hina Khan, MD, hina.khan@lifespan.org
About this study
Official title: Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)
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.
- Conditions
- NSCLC, Stage III, Locally Advanced Lung Carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving standard of care durvalumab | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or higher adverse events (AE's)
CTCAE 5.0
Measured: Up to 18 months
Longitudinal changes in Microbiome
Metagenomic sequencing and taxonomic analysis
Measured: Up to 18 months from study start
Longitudinal changes in bacterial metabolic pathway
Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping
Measured: Up to 18 months from study start
Secondary outcomes (3)
Time-to-treatment withheld due to AEs
Time measured by days
Measured: Up to 18 months from study start
Time to immune-mediated AEs requiring systemic intervention
Time measured by days
Measured: Up to 18 months from study start
Progression free survival
Time measured by months
Measured: Up to 36 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start12 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NSCLC, Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
- Responsible party
- Sponsor-investigator, Jun Zhang, MD, PhD, University of Kansas Medical Center
- Investigators
- Jun Zhang, MD, PhD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680377
- Sponsor's protocol ID
- IIT-2019-AZmicrobiome
- Acronym
- Microdurva
- Status last verified
- May 2024
- First submitted
- 17 Dec 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29781826Strouse 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.
PubMed 30183502