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Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04153097
Collaborator
(none)
500
Enrollment
8
Locations
27.1
Anticipated Duration (Months)
62.5
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pembrolizumab is a humanized antibody used in cancer immunotherapy.The NMPA(China) approved pembrolizumab for first-line treatment of certain patients with advanced NSCLC.

    This is a multi-center non-interventional study, advanced NSCLC patients who treated with pembrolizumab and provide written informed consent will be included. The main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced NSCLC.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
    Actual Study Start Date :
    Jul 30, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2021
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    pembrolizumab-treated advanced NSCLC

    Patients with advanced non-small cell lung cancer treated with pembrolizumab

    Outcome Measures

    Primary Outcome Measures

    1. Median Overall survival (OS) since start of pembrolizumab [3 years]

      OS was defined as the length of time from the administration of the first-dose until death from any cause.

    2. Objective Response Rate (ORR) since start of pembrolizumab [6 months]

      ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to irRECIST.

    3. Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab [up to 3 months after the last dose]

      Drug related AEs were evaluated using NCI-CTCAE v5.0

    Secondary Outcome Measures

    1. Median Progression Free Survival (PFS) since start of pembrolizumab [12 months]

      PFS is defined as the time from the start of first-dose to first progression disease (PD) or death, whichever is earlier.

    2. Median Time To Treatment failure (TTF) since start of pembrolizumab [12 months]

      TTF is defined as the time from the start of first-dose to discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC

    2. Patients who receive pembrolizumab for advanced NSCLC.

    3. Patients who provided written informed consent.

    Exclusion Criteria:

    1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of College of Medicine Zhejiang University Hangzhou Zhejiang China 310000
    2 Second Affiliated Hospital, Zhejiang University of Medicine Hangzhou Zhejiang China 310009
    3 the First Hospital of Jiaxing Jiaxing Zhejiang China 314001
    4 Jinhua Guangfu Hospital Jinhua Zhejiang China 321000
    5 Ningbo Medical Center Lihuili Eastern Hospital Ningbo Zhejiang China 315040
    6 Quzhou People's Hospital Quzhou Zhejiang China 324000
    7 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000
    8 The People's Hospital of Zhuji Zhuji Zhejiang China 310020

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    • Principal Investigator: Jianying Jianying, MD, First Affiliated Hospital of Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04153097
    Other Study ID Numbers:
    • ZYHX-001
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by First Affiliated Hospital of Zhejiang University
    Non-small Cell Lung Cancer
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jan 5, 2021