A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
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
1 other identifier
observational
939
1 country
1
Brief Summary
A Retrospective Study of the Effectiveness and Safety of Nivolumab in Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients in Japan
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 3, 2022
January 1, 2022
9 months
September 5, 2017
January 20, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
NSCLC patients
Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016
Eligibility Criteria
Previously treated advanced/metastatic NSCLC patients treated with nivolumab in Japan.
You may qualify if:
- Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016
You may not qualify if:
- History of participation in any clinical trials prior- or post-nivolumab treatment
- Patients who are a part of a Post-marketing surveillance study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (1)
Local Institution
Minato-ku, Tokyo, 1050001, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 6, 2017
Study Start
April 1, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2018
Last Updated
February 3, 2022
Record last verified: 2022-01