An observational study in Non-small Cell Lung Cancer, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by First Affiliated Hospital of Zhejiang University · Observational
This observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of Chinese advanced NSCLC.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 500 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.
Exclusion Criteria:
1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
Patients with advanced non-small cell lung cancer treated with pembrolizumab
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.
Time frame: 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.
Time frame: 6 months
Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab
Drug related AEs were evaluated using NCI-CTCAE v5.0
Time frame: up to 3 months after the last dose
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.
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: No — No plan to share date of the trial
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
First Affiliated Hospital of Zhejiang University