Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer
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.
Interventions
None listed
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactJianying Zhou, MD
Backup ContactJianya Zhou, MD
Outcome results
None listed