Ex Vivo Tumoroids for Non-Small Cell Lung Cancer

(TUMORIN Trial)

Recruiting at 1 trial location

Overseen By Darlene Kocher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jun Zhang, MD, PhD

Must be taking: Anti-PD-1/L1, Anti-CTLA-4

Disqualifiers: Incarcerated, Not competent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict the effectiveness of immune therapy for individuals with advanced lung cancer. Researchers aim to determine if a small cancer sample from a patient can help test treatments in the lab before applying them to the patient. This trial targets those who have not yet undergone immune therapy and have lung cancer that has spread or is very advanced. Participants must have a cancer spot that can be safely biopsied for testing. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer therapy.

What prior data suggests that this method is safe for patients with advanced/metastatic NSCLC?

Research has shown that ex vivo tumoroids, which are 3D cell models made from a patient's tumor, can help predict how a patient's cancer might respond to treatments. Studies have found that these tumoroids closely resemble the actual tumor in the body, providing a good indication of potential treatment outcomes.

Creating and testing these tumoroids does not involve administering new drugs or treatments to patients. Instead, small samples of a patient’s tumor are used to test different treatments in a lab. As a result, there are no reports of side effects or safety concerns directly related to using ex vivo tumoroids in patients. The primary goal is to assess their ability to predict treatment outcomes, not to test the safety of a new drug.

Overall, using ex vivo tumoroids is considered safe because it does not involve direct treatment of the patient. Instead, it uses a piece of the tumor to gain insights into the cancer and its potential response to treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ex vivo tumoroids to predict immunotherapy response in non-small cell lung cancer (NSCLC) because this method offers a personalized approach to treatment. Unlike traditional therapies that rely on a one-size-fits-all approach, this technique creates miniature tumor models from a patient's own cancer cells to test how they respond to different immunotherapies before actual treatment. This could allow doctors to tailor treatments specifically to how a patient's cancer will react, potentially increasing the effectiveness and reducing unnecessary side effects. Additionally, this method might streamline the process of identifying the most effective treatment options much faster than current methods.

What evidence suggests that this trial's methods could be effective for non-small cell lung cancer?

Studies have shown that lab-grown mini-tumors, called ex vivo tumoroids, can help predict how well patients with non-small cell lung cancer (NSCLC) will respond to certain treatments. One study demonstrated that these mini-tumors indicated a drug called pembrolizumab could kill 40-78% of cancer cells in patient samples. This method uses both cancer and immune cells from patients, allowing researchers to observe how the immune system attacks the tumor. Early findings suggest that this approach can help customize treatments for individual patients, potentially leading to better results. While more research is needed, the initial results are promising for using these mini-tumors in treating advanced NSCLC. ^{2 3 6 7 8}

Who Is on the Research Team?

Jun Zhang, MD, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Measurable disease by RECIST 1.1

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immune checkpoint inhibitors as part of the standard of care

2 years

Ex Vivo Tumoroid Evaluation

Development and evaluation of 3D ex-vivo tumoroids using fresh biopsied tissue from NSCLC patients

Concurrent with treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Jun Zhang, MD, PhD

Lead Sponsor

Trials

5

Recruited

220+

Nilogen Oncosystems

Industry Sponsor

Trials

2

Recruited

50+

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT098/761595/Abstract-CT098-Preliminary-report-of-the-TUMORIN

Abstract CT098: Preliminary report of the TUMORIN Trial ... In ex vivo tumor cell-killing assays, pembrolizumab demonstrated the highest efficacy (40-78% tumor cell death) in tumoroids from four patients, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352364/

Development of Ex Vivo Analysis for Examining Cell ... - PMC We developed a technique for ex vivo isolation of cancer and immune cells from surgical tumor and lung tissue samples of patients with NSCLC.

3. science.org science.org/doi/10.1126/sciadv.adq6830

Ex vivo modeling of precision immuno-oncology responses ... We developed a precision ex vivo platform that integrates patient-specific tumor and immune cells to study the mechanisms of antitumor immune response.

4. nilogen.com nilogen.com/news/nilogen-oncosystems-announces-opening-of-clinical-trial-using-ex-vivo-tumoroids-to-predict-immunotherapy-response-in-non-small-cell-lung-cancer-tumorin/

Nilogen Oncosystems Announces Opening of Clinical Trial ... Nilogen Oncosystems Announces Opening of Clinical Trial Using Ex Vivo Tumoroids to Predict Immunotherapy Response in Non-Small Cell Lung Cancer (TUMORIN).

5. tlcr.amegroups.org tlcr.amegroups.org/article/view/43487/html

Ex vivo culture of circulating tumour cells derived from non ... We were able to detect CTCs in >50% of NSCLC patients. NSCLC patients with >2 CTCs had a poor prognosis. The short-term CTC culture success rate was 12.9%.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05332925

Study Details | NCT05332925 | Using Ex Vivo Tumoroids ... The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be ...

7. esmoopen.com esmoopen.com/article/S2059-7029(20)30140-X/fulltext

Ex vivo lung cancer spheroids resemble treatment ... In this work, we present a clinical case of a patient with non-small cell lung cancer (NSCLC) accompanied by a translational study with the intent to assess the ...

8. mdpi.com mdpi.com/2072-6694/17/6/986

Ex-Vivo Drug-Sensitivity Testing to Predict Clinical ... Background/objectives: Non-small cell lung cancer and pleural mesothelioma are among the most lethal and therapy-resistant tumors in humans.