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NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy

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ClinicalTrials.gov Identifier: NCT04636047
Recruitment Status : Unknown
Verified November 2020 by Lu Shun, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Lu Shun, Shanghai Chest Hospital

Study Description
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Brief Summary:
Liquid biopsy based on next-generation sequencing (NGS) method has become an increasingly powerful detection tool for clinical research and practice. As a companion diagnostic panel, circulating tumor DNA (ctDNA) assay has the considerable potential to detect the blood tumor mutation burden (bTMB), and bTMB calculated by ctDNA assay is regarded as a novel and promising biomarker for immunotherapy nowadays. Though immune checkpoint inhibitors (ICIs) in immunotherapy are highly effective but can induce severe immune-related adverse events (irAEs), which cannot be better predicted in advance. Meanwhile adoptive transfer of T cells transgenic for tumor-reactive T-cell receptors (TCR) is an attractive immunotherapeutic approach. However, clinical translation is so far limited due to challenges in the identification of suitable target antigens as well as TCRs that are concurrent safe and efficient. Definition of key characteristics relevant for effective and specific tumor rejection is essential to improve current TCR-based immunotherapy. This research is to characterize in-depth TCRs derived from HLA-mismatched allogeneic repertoire targeting different myeloperoxidase (MPO)-derived peptides presented by the same HLA-restriction element. Overall the purpose of this trial is to investigate the combined predictive biomarkers (including bTMB and HLA) related to the immunotherapy effects and the biomarker (TCR) associated with adverse reactions during immunotherapy and hold a predictive role, thus further benefit patients receiving immunotherapy, especially in the advanced stage lung cancer patients where tissue samples are unavailable.

Condition or disease Intervention/treatment
Lung Cancer Other: The method of gene mutation detection

Detailed Description:
Blood samples including the plasma and PBMC (peripheral blood mononuclear cell) from immunotherapy-naive lung cancer patients will be analyzed by CGP panel (OrigiMed, Inc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, bTMB, HLA, etc. Treatment methods and outcomes will be followed-up to inspect the clinical benefit and safety with CGP-panel analysis.
Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study on NGS-based Comprehensive Genomic ctDNA Panel in NSCLC Treated With Immunotherapy
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: The method of gene mutation detection
    All samples were detected by NGS CGP panel.

Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: through the whole study period, an average of 3 years ]
    PFS will be defined as the time from initial treatment to the time of disease progression or death

  2. Blood Tumor Mutational Burden (bTMB) [ Time Frame: halfway of the study, an average of 1 year ]
    bTMB will be defined as the total number of detected somatic mutation counts in coding regions per million bases in plasma ctDNA


Secondary Outcome Measures :
  1. Other biomarkers [ Time Frame: halfway of the study, an average of 1 year ]
    The distribution and clinical applications including benefit and adverse reaction of biomarkers such as HLA, TCR and gene mutations in Chinese non-small cell lung cancer patients

  2. Clonality [ Time Frame: halfway of the study, an average of 1 year ]
    The tumor clonality in Chinese non-small cell lung cancer

  3. Overall survival (OS) [ Time Frame: through the whole study period, an average of 3 years ]
    OS will be defined as the time from cancer diagnosed time to the time of death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients in Shanghai Chest Hospital
Criteria

Inclusion Criteria:

  • Participant aged 18 or above, and gender unrestricted
  • Individual with pathologically diagnosed lung cancer

Exclusion Criteria:

  • Patients with concomitant other tumors
  • Individual with severe cardiopulmonary insufficiency and hypoproteinemia
  • Women who were pregnant and were during their lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636047


Contacts
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Contact: Xiaomin Niu 021-22200000-3403 ar_tey@hotmail.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Xiaomin Niu       ar_tey@hotmail.com   
Sponsors and Collaborators
Shanghai Chest Hospital
More Information
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Responsible Party: Lu Shun, Principal Investigator, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT04636047    
Other Study ID Numbers: ShanghaiChest0016
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No