A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan

Study Overview
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Brief Summary
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A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan

Official Title
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Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients - Retrospective Study of Japanese Real-World Data Through Clinical Chart Review

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016 Exclusion Criteria: Patients who meets the inclusion criteria will be included in the analysis to describe real-world clinical usage of nivolumab. However, patients treated with nivolumab falling in following criteria will be excluded for analysis for the other primary endpoint; overall effectiveness: History of participation in any clinical trials prior- or post-nivolumab treatment Patients who are a part of a Post-marketing surveillance study Other protocol defined inclusion/exclusion criteria could apply
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 |
| --- | --- |
| NSCLC patients<br>Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of clinical usage of nivolumab in previously treated NSCLC patients |  | Approximately 9 months | 
| Overall Survival (OS) | Measured from time of initial diagnosis and treatment with nivolumab until date of death | Approximately 9 months | 
| Progression Free Survival (PFS) | Time since index date (initial diagnosis and treatment with nivolumab) to either the first disease progression date or last known tumor assessment date, or death due to any cause, whichever occurs first | Approximately 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving bi-weekly nivolumab |  | Approximately 9 months | 
| Percentage of patients receiving monotherapy or combination therapy |  | Approximately 9 months | 
| Percentage of patients receiving nivolumab as second or later line of therapy |  | Approximately 9 months | 
| Median treatment duration and range by line and histology |  | Approximately 9 months | 
| Rate of permanent and temporary discontinuations |  | Approximately 9 months | 
| Reasons for discontinuation of nivolumab |  | Approximately 9 months | 
| Reasons for re-challenge of nivolumab |  | Approximately 9 months | 
| Objective Response Rate (ORR) as assessed by investigator | ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment | Approximately 9 months |