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

April 22, 2024 updated by: Elephas

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

The primary objective of this study is to determine the ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform using in-vivo RECIST 1.1 as the reference method.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer is a leading cause of death and despite many new drugs, a major diagnostic challenge remains knowing which drug will work best for a patient. A new class of drugs called immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, current diagnostic methods (e.g. PDL1, MSI and TMB) do not accurately predict which patients will respond.

Elephas is developing a diagnostic platform using small 3D Live Tumor Fragments (LTFs) from participants for accurate prediction of drug response with a focus on ICIs such as Pembrolizumab (Keytruda). These LTFs contain both tumor cells and infiltrating immune cells, which are critical in determining response to ICIs and other immunotherapies.

In this observational clinical trial, 200 Non-Small Cell Lung Cancer (NSCLC) participants will be recruited and their actual clinical response to ICIs (using RECIST 1.1) will be compared to the platform's predictive Artificial Intelligence (AI) score that is based on RNA, clinical data, and 3D microscopy images. The sensitivity and specificity of the platform's score will be determined and compared to current diagnostic methods for ICIs like PDL1, MSI, and TMB.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Fereidoun Abtin, MD
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Not yet recruiting
        • James M Stockman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Heather Chalfin, MD
    • New York
      • Shirley, New York, United States, 11967
        • Not yet recruiting
        • New York Cancer & Blood Specialists
        • Principal Investigator:
          • Richard Zuniga, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Terminated
        • University of North Carolina at Chapel Hill
    • Ohio
      • Canton, Ohio, United States, 44718
        • Terminated
        • Gabrail Cancer Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • JPS Health Network
        • Contact:
        • Principal Investigator:
          • Paras Patel, MD
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alan Gowan, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suspected of or diagnosed with metastatic non-small cell lung cancer (NSCLC).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC)

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.
Procedure: Core Needle or Forceps Biopsy
Subjects must be clinically able, at investigator discretion, to undergo additional core needle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors
Time Frame: 3 years
The ex-vivo prognostic accuracy of the Cybrid live tumor diagnostic platform will be determined using in-vivo RECIST 1.1 as the reference method.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the Area Under the Receiver Operating Characteristic Curve (AUC) of Cybrid Score and Compare to the AUCs of Current FDA Approved Predictive Biomarkers PD-L1 and Tumor Mutation Burden (TMB)
Time Frame: 3 years
The AUC of Cybrid Score will be established with a clinically meaningful confidence interval and compared to the AUCs of established FDA approved biomarkers for predicting clinical response to ICIs.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elephas

Collaborators

Beaufort CRO

Investigators

  • Study Director: Fred Hausheer, MD, FACP, Elephas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEP-2022-CYBRID-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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