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NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy

NCT ID: NCT04636047

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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The method of gene mutation detection

All samples were detected by NGS CGP panel.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lu Shun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomin Niu

Role: CONTACT

Phone: 021-22200000-3403

Email: [email protected]

Facility Contacts

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Xiaomin Niu

Role: primary

Other Identifiers

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ShanghaiChest0016

Identifier Type: -

Identifier Source: org_study_id