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CONFIDENCE: Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients

Sponsor
Hunan Province Tumor Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05129462
Collaborator
(none)
52
Enrollment
1
Location
37.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    52 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Consistency of Immunohistochemical Detecting Assays Using E1L3N and 22C3 Monoclonal Antibodies for Detection of PD-L1 Expression in NSCLC Patients: A Prospective CONFIDENCE Study
    Actual Study Start Date :
    Aug 5, 2018
    Actual Primary Completion Date :
    Sep 5, 2021
    Actual Study Completion Date :
    Oct 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Consistency [August 2018- September 2021]

      the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3

    Secondary Outcome Measures

    1. PFS [August 2018- September 2021]

      Progression free survival time

    2. ORR [August 2018- September 2021]

      Objective response rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. ≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;

    2. Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm

    Exclusion Criteria:

    1. Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells <100);

    2. K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;

    3. Other situations that the investigator thinks are not suitable for participating in this clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hunan Cancer Hospital Changsha Hunan China 410013

    Sponsors and Collaborators

    • Hunan Province Tumor Hospital

    Investigators

    • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor Hospital
    ClinicalTrials.gov Identifier:
    NCT05129462
    Other Study ID Numbers:
    • CONFIDENCE
    First Posted:
    Nov 22, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Dec 3, 2021