Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
1 other identifier
observational
500
1 country
8
Brief Summary
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedStudy Start
First participant enrolled
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 16, 2023
August 1, 2022
3.3 years
November 4, 2019
February 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Median Overall survival (OS) since start of pembrolizumab
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
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
Drug related AEs were evaluated using NCI-CTCAE v5.0
up to 3 months after the last dose
Secondary Outcomes (2)
Median Progression Free Survival (PFS) since start of pembrolizumab
12 months
Median Time To Treatment failure (TTF) since start of pembrolizumab
12 months
Study Arms (1)
pembrolizumab-treated advanced NSCLC
Patients with advanced non-small cell lung cancer treated with pembrolizumab
Eligibility Criteria
Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.
You may qualify if:
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
- Patients who receive pembrolizumab for advanced NSCLC.
- Patients who provided written informed consent.
You may not qualify if:
- Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000, China
Second Affiliated Hospital, Zhejiang University of Medicine
Hangzhou, Zhejiang, 310009, China
the First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
Jinhua Guangfu Hospital
Jinhua, Zhejiang, 321000, China
Ningbo Medical Center Lihuili Eastern Hospital
Ningbo, Zhejiang, 315040, China
Quzhou People's Hospital
Quzhou, Zhejiang, 324000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The People's Hospital of Zhuji
Zhuji, Zhejiang, 310020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianying Jianying, MD
First Affiliated Hospital of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
July 30, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
February 16, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
No plan to share date of the trial