Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT04153097
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- Brief Summary
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC
- Patients who receive pembrolizumab for advanced NSCLC.
- Patients who provided written informed consent.
1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (8)
Second Affiliated Hospital, Zhejiang University of Medicine
🇨🇳Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Eastern Hospital
🇨🇳Ningbo, Zhejiang, China
the First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China
Jinhua Guangfu Hospital
🇨🇳Jinhua, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Quzhou People's Hospital
🇨🇳Quzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The People's Hospital of Zhuji
🇨🇳Zhuji, Zhejiang, China