Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)

NCT04923802 | Terminated

• 1 other identifier: MOTIVATION
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Neoantigen; Next-generation Sequencing; Biomarker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overall survival (OS)

  2 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bo Zhu

  Xinqiao Hospital of Chongqing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 11, 2021
• Study Start: June 24, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)