Collecting tumor tissue to improve lung cancer diagnostics

Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)

This study is testing a new way to use live tumor samples to see if it can better predict how well certain lung cancer treatments will work for people with advanced non-small cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elephas (Industry-sponsored)
• Drugs / interventions: Pembrolizumab
• Locations: 7 sites (Los Angeles, California and 6 other locations)
• Trial ID: NCT05478538 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the accuracy of the Cybrid live tumor diagnostic platform in predicting responses to immune checkpoint inhibitors (ICIs) in patients with metastatic non-small cell lung cancer (NSCLC). By recruiting 200 participants, the study will compare the platform's predictive AI score, derived from live tumor fragments, against actual clinical responses measured by RECIST 1.1. The goal is to enhance the understanding of which patients are likely to benefit from specific cancer treatments, particularly ICIs like Pembrolizumab. The study will also assess the sensitivity and specificity of this new diagnostic method compared to existing approaches.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected or diagnosed Stage IV metastatic non-small cell lung cancer.

Not a fit: Patients with early-stage lung cancer or those not diagnosed with NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate predictions of treatment responses in lung cancer patients, improving personalized treatment strategies.

How similar studies have performed: While the approach of using live tumor fragments for diagnostics is innovative, similar studies have shown promise in improving cancer treatment predictions.

Eligibility criteria

Subject Inclusion Criteria

1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Age ≥ 18 years at the time of consent.
3. Subjects suspected of or diagnosed with Stage IV/metastatic 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 previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease.
   3. Subjects who have a newly confirmed diagnosis of Stage IV NSCLC, have undergone a SOC biopsy procedure and will undergo a separate procedure for the purposes of this study prior to starting first line treatment.
   4. Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.
4. Subjects must be clinically able, at investigator discretion, to undergo additional CNB or forceps biopsy passes during their biopsy. These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to additional passes (e.g., liver or lymph nodes) per the clinician.
5. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.

Subject Exclusion Criteria

1. Any patient for whom an extra biopsy might pose a clinical risk based on the discretion of the clinician.
2. Any mental impairment that would render the patient unable to understand his/her participation in the study would disqualify the patient from consenting and participating.
3. Subjects with an auto-immune disease that would render them ineligible for immune- oncology treatment.
4. Immunocompromised subjects, and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinician evidence of an immunocompromised state, are eligible for this trial.
5. Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.
6. Subjects who are pregnant are not eligible.

Where this trial is running

Los Angeles, California and 6 other locations

• UCLA Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
• James M Stockman Cancer Institute — Frederick, Maryland, United States (Recruiting)
• New York Cancer & Blood Specialists — Shirley, New York, United States (Not_yet_recruiting)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Terminated)
• Gabrail Cancer Center — Canton, Ohio, United States (Terminated)
• JPS Health Network — Fort Worth, Texas, United States (Recruiting)
• Baylor Scott & White Research Institute — Temple, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Catarina Costa

Conditions Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer; NSCLC; Metastatic NSCLC - Non-Small Cell Lung Cancer; Metastatic NSCLC; Core needle biopsy; Live tumor fragments; Immunotherapy