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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pembrolizumab-treated advanced NSCLC | Patients with advanced non-small cell lung cancer treated with pembrolizumab |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
| Rate of Adverse Drug Reaction (ADR) since start of pembrolizumab | Drug related AEs were evaluated using NCI-CTCAE v5.0 | up to 3 months after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Median Time To Treatment failure (TTF) since start of pembrolizumab |
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Inclusion Criteria:
Exclusion Criteria:
1.Patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment
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Total 500 patients who receive pembrolizumab for advanced NSCLC will be enrolled. The patients should be registered consecutively in each site.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianying Zhou, MD | Contact | 13505719970 | drzjy@163.com | |
| Jianya Zhou, MD | Contact | 13858123060 | zhoujianya@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianying Jianying, MD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of College of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
No plan to share date of the trial
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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. |
| 12 months |
| Second Affiliated Hospital, Zhejiang University of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| the First Hospital of Jiaxing | Recruiting | Jiaxing | Zhejiang | 314001 | China |
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| Jinhua Guangfu Hospital | Recruiting | Jinhua | Zhejiang | 321000 | China |
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| Ningbo Medical Center Lihuili Eastern Hospital | Recruiting | Ningbo | Zhejiang | 315040 | China |
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| Quzhou People's Hospital | Recruiting | Quzhou | Zhejiang | 324000 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| The People's Hospital of Zhuji | Recruiting | Zhuji | Zhejiang | 310020 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |