Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

Overview

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2023

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.

Arms, Groups and Cohorts

  • pembrolizumab-treated advanced NSCLC
    • Patients with advanced non-small cell lung cancer treated with pembrolizumab

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital of Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jianying Jianying, MD, Principal Investigator, First Affiliated Hospital of Zhejiang University
  • Overall Contact(s)
    • Jianying Zhou, MD, 13505719970, drzjy@163.com

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