Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
- Conditions
- Metastatic NSCLC - Non-Small Cell Lung CancerNon Small Cell Lung CancerNSCLCMetastatic Non Small Cell Lung Cancer
- Interventions
- Procedure: Core Needle or Forceps Biopsy
- Registration Number
- NCT05478538
- Lead Sponsor
- Elephas
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stage IV or metastatic Non Small Cell Lung Cancer (NSCLC) Core Needle or Forceps Biopsy 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.
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of Cybrid Score for Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (7)
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Baylor Scott & White Research Institute
🇺🇸Temple, Texas, United States
New York Cancer & Blood Specialists
🇺🇸Shirley, New York, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
James M Stockman Cancer Institute
🇺🇸Frederick, Maryland, United States
JPS Health Network
🇺🇸Fort Worth, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States