Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform

NCT05478538 | Active Not Recruiting

• 1 other identifier: ELEP-2022-CYBRID-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

NSCLC (Non-small Cell Lung Cancer); Metastatic NSCLC - Non-Small Cell Lung Cancer

Keywords

Metastatic NSCLC; NSCLC; Non Small Cell Lung Cancer; Core needle biopsy; Live tumor fragments; Immunotherapy; Immunotherapy prediction; 3D culture; Ex vivo platform; Immune checkpoint inhibitors; Forceps biopsy; Punch biopsy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors

  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 Outcomes (1)

• 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)

  3 years

Study Arms (1)

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, Forceps, or Punch Biopsy

Interventions

Core Needle, Forceps, or Punch Biopsy PROCEDURE

Subjects must be clinically able, at investigator discretion, to undergo additional core needle, forceps, or punch biopsy 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.

Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Age ≥ 18 years at the time of consent.
• Subjects suspected of or diagnosed with Stage IV/metastatic NSCLC and meet one of the following criteria:
• Subjects who are undiagnosed, have undergone imaging and are suspected to have Stage IV lung cancer.
• Subjects with a previous Stage I, II, or III diagnosis of NSCLC, who are being re-biopsied due to suspected progression to metastatic disease.
• 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.
• Subjects who have a previous Stage IV/metastatic NSCLC diagnosis and have already received first line treatment.
• 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.
• 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.

You may not qualify if:

• Any patient for whom an extra biopsy might pose a clinical risk based on the discretion of the clinician.
• 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.
• Subjects with an auto-immune disease that would render them ineligible for immune- oncology treatment.
• 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.
• Subjects who are enrolled or plan to be enrolled in a blinded oncology treatment trial are not eligible.
• Subjects who are pregnant are not eligible.

Sponsors & Collaborators

• Elephas: lead

Study Sites (7)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

James M Stockman Cancer Institute

Frederick, Maryland, 21702, United States

Location

New York Cancer & Blood Specialists

Shirley, New York, 11967, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Baylor Scott & White Research Institute

Temple, Texas, 76508, United States

Location

Related Publications (6)

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.

  PMID: 28271869 BACKGROUND

• Chen S, Zhang Z, Zheng X, Tao H, Zhang S, Ma J, Liu Z, Wang J, Qian Y, Cui P, Huang D, Huang Z, Wu Z, Hu Y. Response Efficacy of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Apr 16;11:562315. doi: 10.3389/fonc.2021.562315. eCollection 2021.

  PMID: 33937012 BACKGROUND

• Cherukuri AR, Lubner MG, Zea R, Hinshaw JL, Lubner SJ, Matkowskyj KA, Foltz ML, Pickhardt PJ. Tissue sampling in the era of precision medicine: comparison of percutaneous biopsies performed for clinical trials or tumor genomics versus routine clinical care. Abdom Radiol (NY). 2019 Jun;44(6):2074-2080. doi: 10.1007/s00261-018-1702-1.

  PMID: 30032384 BACKGROUND

• Basumallik N, Agarwal M. Small Cell Lung Cancer. 2023 Jul 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482458/

  PMID: 29494065 BACKGROUND

• Ramasubramanian TS, Adstamongkonkul P, Scribano CM, Johnson C, Caenepeel S, Hrycyniak LCF, Vedder L, Dana N, Baltes C, Browning T, Chen YI, Dietz T, Flietner E, Kaplewski N, Kellner A, Korrer M, Liu C, Marhefke N, McDonnell P, Nasreen A, Pope V, Prasad A, Richardson J, Schneider S, Schultz M, Sood C, Sunil A, von Euw E, Wait E, Wargowski E, Advani P, Broome B, Bruckbauer A, Godwin A, Kokabi N, Martin R, Robaina M, Toia G, Routh J, Friedl A, Eliceiri K, Szulczewski M, Johnson S, Oliner J, Galon J, Capitini C, Mukhopadhyay D, Taube J, Braun D, Gierman HJ. A live tumor fragment platform to assess immunotherapy response in core needle biopsies while addressing challenges of tumor heterogeneity. bioRxiv [Preprint]. 2025 Jul 18:2025.07.18.663728. doi: 10.1101/2025.07.18.663728.

  PMID: 40791544 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tissue sampling using core needle, forceps, or punch biopsy

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Biopsy, Needle; Surgical Instruments

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Surgical Equipment; Equipment and Supplies

Study Officials

• Fred Hausheer, MD, FACP

  Elephas

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: January 31, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)