Tissue Collection for Lung Cancer

(CYBRID-01 Trial)

Recruiting at 5 trial locations

Overseen By Jonathan Oliner, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elephas

Must not be taking: Antiretrovirals

Disqualifiers: Auto-immune disease, Immunocompromised, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing lung cancer using the Cybrid live tumor diagnostic platform. It compares this method with the existing imaging standard, RECIST 1.1, to evaluate its effectiveness in predicting lung cancer progression. The trial involves a core needle biopsy to collect tissue samples from tumors. It seeks participants who suspect they have Stage IV non-small cell lung cancer (NSCLC) or have a confirmed diagnosis, particularly those about to start or who have just started treatment. Participants must be able to undergo additional biopsy procedures without clinical risk. As a Phase 2 trial, this research measures the diagnostic method's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in lung cancer diagnosis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What prior data suggests that the Cybrid live tumor diagnostic platform is safe for use in diagnosing NSCLC?

Research has shown that a core needle biopsy, which involves taking a small tissue sample from the lung, is generally safe and well-tolerated. This method is minimally invasive, requiring neither large cuts nor a long recovery time.

One study found that using ultrasound to guide a lung biopsy, a type of core needle biopsy, was safe for patients. This procedure provided high-quality tissue samples needed for an accurate diagnosis. Another report confirmed that these biopsies effectively detect lung cancer and can be safely performed even in patients with advanced lung cancer.

Overall, a core needle biopsy is considered a reliable and safe way to collect tissue samples for diagnosing lung conditions, including cancer. However, like any medical procedure, some risks may exist, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to refine the way we diagnose Stage IV or metastatic Non-Small Cell Lung Cancer (NSCLC). Unlike standard diagnostic methods, which rely heavily on imaging and initial biopsies, this trial focuses on using core needle biopsies to gather live tumor tissue. This approach could lead to more accurate and timely diagnosis, potentially improving how quickly and effectively doctors can tailor treatments for patients. By validating a live tumor diagnostic platform, the trial could pave the way for real-time insights into tumor behavior, offering a significant leap forward in personalized cancer care.

What evidence suggests that the Cybrid live tumor diagnostic platform is effective for Stage IV or metastatic NSCLC?

This trial involves participants with Stage IV or metastatic Non-Small Cell Lung Cancer (NSCLC) undergoing core needle biopsy. Studies have shown that core needle biopsy effectively diagnoses lung cancer. Research indicates that 82.9% of biopsy samples provide sufficient tumor tissue for analysis, enabling doctors to check important signals in the body that guide treatment. In 48 studies, core needle biopsy demonstrated high accuracy, correctly identifying cancer in most cases. This method also allows for the examination of many genes simultaneously, which is crucial for targeting cancer treatments. Therefore, core needle biopsy serves as a reliable tool for examining lung cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Fred Hausheer, MD, FACP

Principal Investigator

Elephas

Are You a Good Fit for This Trial?

Inclusion Criteria

Suspected of or diagnosed with non-small cell lung cancer (NSCLC).

Written informed consent and HIPAA authorization for release of personal health information prior to registration.

ECOG ≤ 3.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Collection

Participants undergo biopsy procedures to collect small 3D Live Tumor Fragments (LTFs) for diagnostic platform development

1-2 weeks

Observational

Participants' clinical responses to ICIs are observed and compared to the platform's predictive AI score

3 years

Follow-up

Participants are monitored for safety and effectiveness after the observational phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core needle biopsy

How Is the Trial Designed?

Group I: Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) Experimental Treatment 1 Intervention

Subjects suspected of or diagnosed with Stage IV NSCLC and meet one of the following criteria: 1. Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer. 2. Subjects with a Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied after imaging-confirmed progression to metastatic disease 3. Subjects who have a confirmed diagnosis of NSCLC, and have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study. 4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.

Who Is Running the Clinical Trial?

Elephas

Lead Sponsor

Trials

2

Recruited

420+

Beaufort CRO

Industry Sponsor

Trials

2

Recruited

3,200+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022522314003213

Outcomes and efficacy of thoracic surgery biopsy for tumor ... These data suggest that thoracic surgical biopsy can be safely performed in appropriately selected patients with stage IV non–small cell lung cancer and direct ...

2. por-journal.com por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2021.1609931/full

Comparison of Multi-Gene Testing Data Between Fresh ... In this study, we evaluated the multi-gene mutation status in fresh tissues and paired FFPE tissues from core needle biopsy for target therapies of patients ...

3. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-023-02321-9

Optimizing molecular testing of lung cancer needle biopsy ... A recent study of advanced NSCLC found that NGS panels had a 39% lower rate of unsuccessful genotyping, resulting in 30% fewer missed treatment ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3879952/

Feasibility of Image-Guided Transthoracic Core Needle ... 82.9% of the biopsy specimens were found to have adequate tumor tissue for analysis of the required biomarkers. On multivariate analysis, metastatic lesions ...

5. shc.amegroups.org shc.amegroups.org/article/view/6893/html

Core needle biopsy for screening detected lung cancer—does ... Pooled data from 48 studies demonstrate a high diagnostic accuracy for both methods. The overall diagnostic accuracy of CT-guided biopsy (FNAB plus CNB) was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11352358/

Molecular Diagnostic Yield and Safety Profile of Ultrasound ... An ultrasound-guided percutaneous lung biopsy performed by a pulmonologist is a safe, minimally invasive procedure for patients with ...

7. nccn.org nccn.org/patients/guidelines/content/PDF/lung-metastatic-patient.pdf

Metastatic Non-Small Cell Lung Cancer If your care team suspects metastatic lung cancer, you may have a biopsy of the metastasis instead of the lung tumor. A biopsy of the metastasis ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)31710-7/fulltext

Metastatic non-small cell lung cancer: ESMO Clinical ... Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up