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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273790
• Other study ID #: CA209-9CR
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 939
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of clinical usage of nivolumab in previously treated NSCLC patients		Approximately 9 months
Primary	Overall Survival (OS)	Measured from time of initial diagnosis and treatment with nivolumab until date of death	Approximately 9 months
Primary	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	Percentage of patients receiving bi-weekly nivolumab		Approximately 9 months
Secondary	Percentage of patients receiving monotherapy or combination therapy		Approximately 9 months
Secondary	Percentage of patients receiving nivolumab as second or later line of therapy		Approximately 9 months
Secondary	Median treatment duration and range by line and histology		Approximately 9 months
Secondary	Rate of permanent and temporary discontinuations		Approximately 9 months
Secondary	Reasons for discontinuation of nivolumab		Approximately 9 months
Secondary	Reasons for re-challenge of nivolumab		Approximately 9 months
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls