Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

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

Detailed Description
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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.

Official Title
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Real World Observational Study of Pembrolizumab for Chinese Advanced NSCLC

Conditions
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Non-small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC Patients who receive pembrolizumab for advanced NSCLC. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pembrolizumab-treated advanced NSCLC<br>Patients with advanced non-small cell lung cancer treated with pembrolizumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer