Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)

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

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.

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.

Inclusion Criteria:

• Patients with stage I-IV non-small cell lung cancer(with no restriction of age, gender, or smoking history)
• Patients in the group will be allowed to collect whole blood and tissue samples at specific time points
• Eastern Cooperative Oncology Group Performance Status of 0-1 within 28 days prior to registration
• No previous systemic anti-tumor therapy
• Signed informed consent

Exclusion Criteria:

• Active or history of autoimmune disease or immune deficiency
• Patients with serious mental disease
• Prior allogeneic stem cell or solid organ transplantation
• Pregnant or lactating women
• Patients who cannot obtain tumor tissue samples and / or whole blood
• Patients with history of blood transfusion within half a year
• Patients with any other malignancy diagnosed within 5 years
• Received systemic anti-tumor therapy