Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04923802
Status:
TERMINATED
Last Update Posted:
2024-03-08
First Post:
2021-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)
Sponsor:
GeneCast Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter Prospective Observational Study of Non-small Cell Lung Cancer Patients for Development and Validation of Computational Method for Multi-omics-based Neoantigen Prediction and Biomarkers for Immunotherapy Response Evaluation
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit sufficient numbers of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTIVATION
Brief Summary:
This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers for evaluation of PD-1/PD-L1 inhibitor's efficacy in patients of advanced NSCLC.
Detailed Description:
Tumor tissues and blood samples from about 400 patients with non-small-cell lung cancer (NSCLC) will be collected for the study, which will be subject to NGS-based genomic, transcriptomic, and methylomic profiling in order to construct a multi-omics landscape of NSCLC. These multi-omics data will be used to construct and validate a novel computational method for neoantigen prediction. Additionally, biomarkers will be explored for prognosis and patient stratification, as well as for evaluation of PD-1/PD-L1 inhibitor treatment efficacy in patients of advanced NSCLC.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: