Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

February 15, 2023 updated by: First Affiliated Hospital of Zhejiang University
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jianying Zhou, MD
  • Phone Number: 13505719970
  • Email: drzjy@163.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital of College of Medicine Zhejiang University
        • Contact:
          • Jianying Zhou, MD
          • Phone Number: 13505719970
          • Email: drzjy@163.com
        • Contact:
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affiliated Hospital, Zhejiang University of Medicine
        • Contact:
      • Jiaxing, Zhejiang, China, 314001
        • Recruiting
        • The First Hospital of Jiaxing
        • Contact:
      • Jinhua, Zhejiang, China, 321000
        • Recruiting
        • Jinhua Guangfu Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315040
        • Recruiting
        • Ningbo Medical Center Lihuili Eastern Hospital
        • Contact:
          • Yaodong Tang, MD
      • Quzhou, Zhejiang, China, 324000
        • Recruiting
        • Quzhou people's Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Zhuji, Zhejiang, China, 310020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
pembrolizumab-treated advanced NSCLC
Patients with advanced non-small cell lung cancer treated with pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Overall survival (OS) since start of pembrolizumab
Time Frame: 3 years
OS was defined as the length of time from the administration of the first-dose until death from any cause.
3 years
Objective Response Rate (ORR) since start of pembrolizumab
Time Frame: 6 months
ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to irRECIST.
6 months
Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
Time Frame: up to 3 months after the last dose
Drug related AEs were evaluated using NCI-CTCAE v5.0
up to 3 months after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Progression Free Survival (PFS) since start of pembrolizumab
Time Frame: 12 months
PFS is defined as the time from the start of first-dose to first progression disease (PD) or death, whichever is earlier.
12 months
Median Time To Treatment failure (TTF) since start of pembrolizumab
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYHX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share date of the trial

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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