Clinical trial NCT04923802: Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-small Cell Lung Cancer
Neoantigen
Next-generation Sequencing
Biomarker
Lead sponsor: GeneCast Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xinqiao Hospital of Chongqing
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Shanghai Chest Hospital
name: Wuhan University
name: Renmin Hospital of Wuhan University
name: Tongji Hospital
name: Southwest Hospital, China
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: People's Hospital of Chongqing
name: Sichuan Cancer Hospital and Research Institute
name: The Second Affiliated Hospital of Kunming Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: The Affiliated Hospital Of Southwest Medical University
name: Guizhou Provincial People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Shanxi Provincial Cancer Hospital
name: First Hospital of China Medical University
name: Fujian Provincial Hospital
name: Peking University Shenzhen Hospital
name: Affiliated Cancer Hospital of Shantou University Medical College
name: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
First posted: 2021-06-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-IV non-small cell lung cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Disease-free survival (DFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Second Affiliated Hospital of Army Medical University
state: Chongqing
Study officials:
affiliation: Xinqiao Hospital of Chongqing
name: Bo Zhu
role: PRINCIPAL_INVESTIGATOR
References: