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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)
- ClinicalTrials.gov ID
- NCT04680377
- Acronym / sponsor ID
- Microdurva / IIT-2019-AZmicrobiome
- Conditions
- NSCLC, Stage III, Locally Advanced Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Jun Zhang, MD, PhDUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade 3 or higher adverse events (AE's)
Time frame: Up to 18 months
CTCAE 5.0
Longitudinal changes in Microbiome
Time frame: Up to 18 months from study start
Metagenomic sequencing and taxonomic analysis
Longitudinal changes in bacterial metabolic pathway
Time frame: Up to 18 months from study start
Metagenomic sequencing and Kyoto Encyclopedia of Genes and Genomes (KEGG) mapping
3 secondary outcomes
Time-to-treatment withheld due to AEs
Time frame: Up to 18 months from study start
Time to immune-mediated AEs requiring systemic intervention
Time frame: Up to 18 months from study start
Progression free survival
Time frame: Up to 36 months from study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 29781826Swami 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.
- Background: PubMed 30183502Strouse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Zhang, MD, PhD principal investigator
The University of Kansas Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, Stage III and Locally Advanced Lung Carcinoma, run by Jun Zhang, MD, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KUCC Navigation (9135883671, kucc_Navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or higher adverse events (AE's) (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04680377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.