Non-small Cell Lung CancerMOTIVATIONNCT04923802
Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)
An observational study of Non-small Cell Lung Cancer and Neoantigen, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Neoantigen, Next-generation Sequencing
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I-IV non-small cell lung cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400000
About this study
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
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.
Read the 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.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start24 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Unable to recruit sufficient numbers of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xinqiao Hospital of Chongqing, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital, Wuhan University, Renmin Hospital of Wuhan University, Tongji Hospital, Southwest Hospital, China, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, People's Hospital of Chongqing, Sichuan Cancer Hospital and Research Institute, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Wenzhou Medical University, The Affiliated Hospital Of Southwest Medical University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shanxi Province Cancer Hospital, First Hospital of China Medical University, Fujian Provincial Hospital, Peking University Shenzhen Hospital, Affiliated Cancer Hospital of Shantou University Medical College, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Bo Zhu, Principal investigator, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923802
- Sponsor's protocol ID
- MOTIVATION
- Acronym
- MOTIVATION
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04923802
- Acronym / sponsor ID
- MOTIVATION / MOTIVATION
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient numbers of patients
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xinqiao Hospital of Chongqing, Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital, Wuhan University, Renmin Hospital of Wuhan University, Tongji Hospital, Southwest Hospital, China, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, People's Hospital of Chongqing, Sichuan Cancer Hospital and Research Institute, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Wenzhou Medical University, The Affiliated Hospital Of Southwest Medical University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shanxi Province Cancer Hospital, First Hospital of China Medical University, Fujian Provincial Hospital, Peking University Shenzhen Hospital, Affiliated Cancer Hospital of Shantou University Medical College, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I-IV non-small cell lung cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival (PFS)
Time frame: 2 years
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
Disease-free survival (DFS)
Time frame: 2 years
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.
1 secondary outcome
Overall survival (OS)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient numbers of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Zhu principal investigator
Xinqiao Hospital of Chongqing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Neoantigen, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit sufficient numbers of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.