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

Recruiting

• Conditions: Metastatic NSCLC - Non-Small Cell Lung Cancer; Non Small Cell Lung Cancer; NSCLC; Metastatic Non Small Cell Lung Cancer

• 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.

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2023-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

James M Stockman Cancer Institute; 🇺🇸 Frederick, Maryland, United States

New York Cancer & Blood Specialists; 🇺🇸 Shirley, New York, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

JPS Health Network; 🇺🇸 Fort Worth, Texas, United States

Baylor Scott & White Research Institute; 🇺🇸 Temple, Texas, United States