Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153097
• Other study ID #: ZYHX-001
• Status: Recruiting
• Start date: July 30, 2020
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Jianying Zhou, MD
• Phone: 13505719970
• Email: drzjy[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of College of Medicine Zhejiang University	Hangzhou	Zhejiang
China	the First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Jinhua Guangfu Hospital	Jinhua	Zhejiang
China	Ningbo Medical Center Lihuili Eastern Hospital	Ningbo	Zhejiang
China	Quzhou People's Hospital	Quzhou	Zhejiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The People's Hospital of Zhuji	Zhuji	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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