NSCLC Stage IVNCT04636775
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
An observational study of NSCLC Stage IV and NSCLC, Recurrent, run by Jun Zhang, MD, PhD at 3 sites in United States.
Trial summary
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, NSCLC, Recurrent
- What is being tested?
- Microbiome
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
Who may be able to join
- Must have tumor tissue biopsy-proven to be NSCLC
- Must have a target lesion to evaluate treatment response
- Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
- Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1
Who cannot join
- Prior treatment with any forms of cancer immunotherapy
- Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement
- Not English-speaking
- Patients that are pregnant
- Prisoners
- Students and employees
- Psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, 66205
KUCC Navigator, 913-588-3671, kucc_navigation@kumc.edu
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
KUCC Navigation, 913-588-3671, kucc_navigation@kumc.edu
About this study
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.
- Conditions
- NSCLC Stage IV, NSCLC, Recurrent
- Being tested
- Microbiome
- Keywords
- Advanced NSCLC, Metastatic NSCLC, Recurrent NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrobiomeDiagnostic test
Nasal and buccal swabs, and stool sample, as well as the extracted DNAs
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy naïve NSCLC patients | Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade Receives: Diagnostic Test: Microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome difference between patients with and without AEs>=grade 3
Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Microbiome difference between responders vs. nonresponders
Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Measured: Through study completion, an average of 1 year
Correlation of microbiome to tumor tissue PD-L1 expression
PD-L1 expression is per standard of care using IHC
Measured: Through study completion, an average of 1 year
Correlation of microbiome to diet
Customized Diet Survey
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start29 Jul 2020
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (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 IVStudies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang, MD, PhD
- Sponsor type
- University, hospital or other
- 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
- NCT04636775
- Sponsor's protocol ID
- IIT-2020-MIP-NSCLC
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2020
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
- ClinicalTrials.gov ID
- NCT04636775
- Acronym / sponsor ID
- IIT-2020-MIP-NSCLC
- Conditions
- NSCLC Stage IV, NSCLC, Recurrent
- Keywords
- Advanced NSCLC, Metastatic NSCLC, Recurrent NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Jun Zhang, MD, PhDUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Nov 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, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy naïve NSCLC patients | – | Diagnostic Test: MicrobiomeMicrobiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
Key inclusion criteria (4 listed)
- Must have tumor tissue biopsy-proven to be NSCLC
- Must have a target lesion to evaluate treatment response
- Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
- Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1
Key exclusion criteria (7 listed)
- Prior treatment with any forms of cancer immunotherapy
- Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement
- Not English-speaking
- Patients that are pregnant
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrobiomeNasal and buccal swabs, and stool sample, as well as the extracted DNAs | Diagnostic test | Immunotherapy naïve NSCLC patients |
Primary outcome
Microbiome difference between patients with and without AEs>=grade 3
Time frame: Through study completion, an average of 1 year
Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
3 secondary outcomes
Microbiome difference between responders vs. nonresponders
Time frame: Through study completion, an average of 1 year
Correlation of microbiome to tumor tissue PD-L1 expression
Time frame: Through study completion, an average of 1 year
Correlation of microbiome to diet
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jun Zhang, MD, PhD principal investigator
The University of Kansas Cancer Center
3 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 IV and NSCLC, Recurrent, run by Jun Zhang, MD, PhD at 3 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Microbiome difference between patients with and without AEs>=grade 3 (time frame: Through study completion, an average of 1 year). 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 NCT04636775, 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 11 Dec 2023.