Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION) (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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer; Biomarker; Next-generation Sequencing; Neoantigen

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

• Study Contact: Name: MS Li; Phone Number: 400-080-0660; Email: info@genecast.com.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Second Affiliated Hospital of Army Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-IV non-small cell lung cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Progression free survival (PFS) is defined as the period a participant remains alive without disease progression after study registration. Tumor status is assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) by computed tomography (CT), positron emission tomography (PET) CT and/or X rays. Complete Response (CR) = Disappearance of all lesions Partial Response (PR) = ≥30% decrease in the sum of the lesion diameters Overall Response (OR) = CR + PR Progressive disease (PD) = 20% increase in the sum of lesion diameters, and/or the appearance of 1+ new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria	2 years
Disease-free survival (DFS)	Disease-free survival (DFS) is defined as the number of participants remaining alive without disease progression (PD), symptomatic deterioration or death due to any cause. DFS is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as follows. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the diameters of target lesions (must be > 5 mm), unequivocal progression of non-target lesions, and/or the appearance of one or more new lesion(s) Stable disease (SD) = Small changes that do not meet any of the above criteria. The outcome will be reported as the number of participants who meet the criteria for DFS, a number without dispersion.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival (OS) defined as the duration from study registration until death due to any cause. The outcome will be reported as the number of participants known to be alive at 24 months after study registration, a number without dispersion.	2 years

Collaborators and Investigators

• Sponsor: GeneCast Biotechnology Co., Ltd.
• Collaborators: Wuhan University; Southwest Hospital, China; Tongji Hospital; The First Affiliated Hospital of Zhengzhou University; Guizhou Provincial People's Hospital; Shanxi Provincial Cancer Hospital; Shanghai Chest Hospital; Renmin Hospital of Wuhan University; Shanghai Pulmonary Hospital, Shanghai, China; Affiliated Cancer Hospital of Shantou University Medical College; Xinqiao Hospital of Chongqing; First Hospital of China Medical University; Peking University Shenzhen Hospital; First Affiliated Hospital of Wenzhou Medical University; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Fujian Provincial Hospital; Sichuan Cancer Hospital and Research Institute; The Affiliated Hospital Of Southwest Medical University; The Second Affiliated Hospital of Kunming Medical University; The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; People's Hospital of Chongqing
• Investigators: Principal Investigator: Bo Zhu, Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: MOTIVATION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No