- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680377
Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients (Microdurva)
Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66205
- Recruiting
- The University of Kansas Cancer Center, Westwood Campus
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Not yet recruiting
- Rhode Island Hospital, Brown University
-
Contact:
- Hina Khan, MD
- Email: hina.khan@lifespan.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade 3 or higher adverse events (AE's)
Time Frame: Up to 18 months
|
CTCAE 5.0
|
Up to 18 months
|
Longitudinal changes in Microbiome
Time Frame: Up to 18 months from study start
|
Metagenomic sequencing and taxonomic analysis
|
Up to 18 months from study start
|
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
|
Up to 18 months from study start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-to-treatment withheld due to AEs
Time Frame: Up to 18 months from study start
|
Time measured by days
|
Up to 18 months from study start
|
Time to immune-mediated AEs requiring systemic intervention
Time Frame: Up to 18 months from study start
|
Time measured by days
|
Up to 18 months from study start
|
Progression free survival
Time Frame: Up to 36 months from study start
|
Time measured by months
|
Up to 36 months from study start
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun Zhang, MD, PhD, The University of Kansas Cancer Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-2019-AZmicrobiome
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NSCLC, Stage III
-
The Netherlands Cancer InstituteAstraZenecaUnknown
-
Indiana UniversityRecruitingNSCLC, Stage IIIUnited States
-
Shanghai Chest HospitalNot yet recruiting
-
Xiaorong DongUnknownHealthy Subjects | NSCLC Stage IV | NSCLC, Stage III | NSCLC, Stage I | NSCLC, Stage IIChina
-
Beijing Tsinghua Chang Gung HospitalRecruiting
-
Zhejiang Cancer HospitalNot yet recruitingUnresectable Stage III NSCLC
-
The First Affiliated Hospital of Guangzhou Medical...RecruitingNSCLC, Stage III | NSCLC, Stage I | NSCLC, Stage IIChina
-
ETOP IBCSG Partners FoundationTakedaRecruitingNSCLC, Stage III | ALK-rearrangementFrance, Spain, Italy, Poland, United Kingdom
-
Arbeitsgemeinschaft medikamentoese TumortherapieRecruitingLung Cancer | NSCLC Stage IV | NSCLC, Stage III | SCLC, Extensive Stage | SCLC, Limited StageAustria
-
Vestre Viken Hospital TrustOdense University Hospital; Karolinska University Hospital; Oslo University Hospital and other collaboratorsRecruitingCancer | Lung Cancer | NSCLC Stage IV | Mutation | NSCLC, Stage III | Lung Cancer Stage IV | Cancer, LungNorway