Non Small Cell Lung CancerNCT06221800
Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects
An observational study of Non Small Cell Lung Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Microbiome
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 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: Patient with advanced/metastatic non-small cell lung cancer (NSCLC)
Who may be able to join
- 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
- 2. The patient himself/herself must be 18 years of age on day of signing informed consent.
- 3. The subject has signed the informed consent form.
- 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.
- 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration
Who cannot join
- 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Misako Nagasaka, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects
This is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Microbiome
- 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.
MicrobiomeDiagnostic test
Stool and saliva samples will be collected
| Study group | Role | What they receive |
|---|---|---|
| Treatment with PD1/L1 monotherapy | Not described Receives: Diagnostic Test: Microbiome | |
| Treatment with PD1/L1 + chemotherapy | Not described Receives: Diagnostic Test: Microbiome | |
| Treatment with Tyrosine Kinase Inhibitor | Not described Receives: Diagnostic Test: Microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiomes in advanced/metastatic NSCLC patients
To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy
Measured: Up to 2 years
Secondary outcomes (4)
Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.
Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan
Measured: Up to 2 years
Clinical Response Rate (RR)
Defined according to RECIST v1.1 criteria
Measured: Up to 2 years
Progression-Free Survival (PFS)
Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
Duration from the start date of treatment to the date of death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start31 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misako Nagasaka, University of California, Irvine
- Investigators
- Misako Nagasaka, MD,PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221800
- Sponsor's protocol ID
- 3887
- Other IDs
- UCI 22-86
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects
- ClinicalTrials.gov ID
- NCT06221800
- Acronym / sponsor ID
- 3887
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jan 2024 (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 is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment with PD1/L1 monotherapy | – | Diagnostic Test: Microbiome |
| Treatment with PD1/L1 + chemotherapy | – | Diagnostic Test: Microbiome |
| Treatment with Tyrosine Kinase Inhibitor | – | Diagnostic Test: Microbiome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with advanced/metastatic non-small cell lung cancer (NSCLC)
Key inclusion criteria (5 listed)
- 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
- 2. The patient himself/herself must be 18 years of age on day of signing informed consent.
- 3. The subject has signed the informed consent form.
- 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.
- 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration
Key exclusion criteria (1 listed)
- 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.
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 |
|---|---|---|
| MicrobiomeStool and saliva samples will be collected | Diagnostic test | Treatment with PD1/L1 + chemotherapy, Treatment with PD1/L1 monotherapy, Treatment with Tyrosine Kinase Inhibitor |
Primary outcome
Gut microbiomes in advanced/metastatic NSCLC patients
Time frame: Up to 2 years
To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy
4 secondary outcomes
Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.
Time frame: Up to 2 years
Clinical Response Rate (RR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
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 5 Feb 2026.
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Misako Nagasaka, MD,PhD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University of California, Irvine at 1 site 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 5 inclusion and 1 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiomes in advanced/metastatic NSCLC patients (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.