Non-Small Cell Lung Cancer
Conditions
Brief summary
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
Interventions
None listed
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of clinical usage of nivolumab in previously treated NSCLC patients | Approximately 9 months | — |
| Overall Survival (OS) | Approximately 9 months | Measured from time of initial diagnosis and treatment with nivolumab until date of death |
| Progression Free Survival (PFS) | Approximately 9 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median treatment duration and range by line and histology | Approximately 9 months | — |
| Rate of permanent and temporary discontinuations | Approximately 9 months | — |
| Percentage of patients receiving bi-weekly nivolumab | Approximately 9 months | — |
| Reasons for re-challenge of nivolumab | Approximately 9 months | — |
| Objective Response Rate (ORR) as assessed by investigator | Approximately 9 months | 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 |
| Reasons for discontinuation of 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 | — |
Countries
Japan
Outcome results
None listed