Lung CancerTUMORINNCT05332925
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
An observational study of Lung Cancer and NSCLC, run by Jun Zhang, MD, PhD at 2 sites in United States.
Trial summary
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Lung Cancer, NSCLC, NSCLC Stage IV
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2022to Feb 2027
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced/metastatic NSCLC patients who are immunotherapy naïve and ready to receive immune checkpoint inhibitors as standard--of-care treatment.
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
- Patients with advanced/metastatic NSCLC
- Must be immunotherapy naive
- Males and females age ≥ 18 years
- ECOG Performance Status 0 - 2
- Measurable disease by RECIST 1.1
Show all 10Show fewer
- Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids
- Must have at least one target lesion to evaluate treatment response
- Will be receiving anti-PD-1/L1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.
- Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care.
Who cannot join
- Incarcerated
- Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
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 (KUCC)
Fairway, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
Steve Williamson, MD, 913-588-3808, SWILLIAM@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
About this study
Official title: Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.
Read the detailed description
Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint inhibitors (ICIs) to target the programmed death-1 and its ligand (PD-1/L1) has revolutionized our management of this deadly disease.
However, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. Hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current SOC immunotherapy are urgently needed to continue to benefit our NSCLC patients.
The investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. In this study, the investigators plan to develop such a 3D ex-vivo system utilizing fresh biopsied tissue from NSCLC patients. The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be receiving anti-PD-1/L1 (with or without anti-CTLA-4) per standard-of-care.
- Conditions
- Lung Cancer, NSCLC, NSCLC Stage IV
- Being tested
- Standard of care immune checkpoint inhbitors
- Keywords
- Tumoroids, Organoids, Immunotherapy, Immune check point inhibitor, Anti-PD-1, Anti-CTLA-4, Ex vivo model, 3D culture
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care immune checkpoint inhbitorsDrug
This is NOT an interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of establishing 3D ex-vivo tumoroid model
Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients.
Measured: 2 years
Secondary outcomes (1)
Correlation of response in ex vivo tumoroids with clinical objective response
To test whether the 3D-EX functional response bioassay can predict tumor response (using RECIST v1.1) in patients with advanced/metastatic NSCLC, receiving treatment with immune checkpoint inhibitors, in a standard clinical setting.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start21 Jul 2022
- Primary completionJan 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Nilogen Oncosystems
- Responsible party
- Sponsor-investigator, Jun Zhang, MD, PhD, University of Kansas Medical Center
- Investigators
- Jun Zhang, MD, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332925
- Sponsor's protocol ID
- IIT-2021-Tumorin
- Acronym
- TUMORIN
- Status last verified
- Feb 2024
- First submitted
- 10 Apr 2022
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)
- ClinicalTrials.gov ID
- NCT05332925
- Acronym / sponsor ID
- TUMORIN / IIT-2021-Tumorin
- Conditions
- Lung Cancer, NSCLC, NSCLC Stage IV
- Keywords
- Tumoroids, Organoids, Immunotherapy, Immune check point inhibitor, Anti-PD-1, Anti-CTLA-4, Ex vivo model, 3D culture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jun Zhang, MD, PhDUniversity, hospital or other
- Collaborators
- Nilogen Oncosystems
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Apr 2022 (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.
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.
Detailed description
Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint inhibitors (ICIs) to target the programmed death-1 and its ligand (PD-1/L1) has revolutionized our management of this deadly disease.
However, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. Hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current SOC immunotherapy are urgently needed to continue to benefit our NSCLC patients.
The investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. In this study, the investigators plan to develop such a 3D ex-vivo system utilizing fresh biopsied tissue from NSCLC patients. The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be receiving anti-PD-1/L1 (with or without anti-CTLA-4) per standard-of-care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced/metastatic NSCLC patients who are immunotherapy naïve and ready to receive immune checkpoint inhibitors as standard--of-care treatment.
Key inclusion criteria (10 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Patients with advanced/metastatic NSCLC
- Must be immunotherapy naive
- Males and females age ≥ 18 years
- ECOG Performance Status 0 - 2
Key exclusion criteria (2 listed)
- Incarcerated
- Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
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 |
|---|---|---|
| Standard of care immune checkpoint inhbitorsThis is NOT an interventional study. | Drug | – |
Primary outcome
Feasibility of establishing 3D ex-vivo tumoroid model
Time frame: 2 years
Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients.
1 secondary outcome
Correlation of response in ex vivo tumoroids with clinical objective response
Time frame: 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 23 Feb 2024.
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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
University of Kansas Medical 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 Lung Cancer and NSCLC, 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 10 inclusion and 2 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 23 Feb 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 Darlene Kocher (9135887132, dkocher@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of establishing 3D ex-vivo tumoroid model (time frame: 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 23 Feb 2024.