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

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT03273790
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 939

Inclusion Criteria

• Previously treated advanced/metastatic NSCLC patients treated with nivolumab at least once from 01-Apr-2016 through 31-Dec-2016

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients receiving nivolumab as second or later line of therapy	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
Percentage of patients receiving monotherapy or combination therapy	Approximately 9 months
Median treatment duration and range by line and histology	Approximately 9 months
Percentage of patients receiving bi-weekly nivolumab	Approximately 9 months
Reasons for discontinuation of nivolumab	Approximately 9 months
Reasons for re-challenge of nivolumab	Approximately 9 months
Rate of permanent and temporary discontinuations	Approximately 9 months

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Minato-ku, Tokyo, Japan