Clinical trial NCT04153097: Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
Official title: Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median Overall survival (OS) since start of pembrolizumab
timeFrame: 3 years
measure: Objective Response Rate (ORR) since start of pembrolizumab
timeFrame: 6 months
measure: Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
timeFrame: up to 3 months after the last dose
Secondary outcomes:
measure: Median Progression Free Survival (PFS) since start of pembrolizumab
timeFrame: 12 months
measure: Median Time To Treatment failure (TTF) since start of pembrolizumab
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: the First Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Guangfu Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Eastern Hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Zhuji
country: China
facility: The People's Hospital of Zhuji
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Jianying Jianying, MD
role: PRINCIPAL_INVESTIGATOR
References: