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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 31, 2019

Interventions

  • Other: Non-interventional
    • Non-interventional

Arms, Groups and Cohorts

  • NSCLC patients
    • Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016

Clinical Trial Outcome Measures

Primary Measures

  • Description of clinical usage of nivolumab in previously treated NSCLC patients
    • Time Frame: Approximately 9 months
  • Overall Survival (OS)
    • Time Frame: Approximately 9 months
    • Measured from time of initial diagnosis and treatment with nivolumab until date of death
  • Progression Free Survival (PFS)
    • Time Frame: 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 Measures

  • Percentage of patients receiving bi-weekly nivolumab
    • Time Frame: Approximately 9 months
  • Percentage of patients receiving monotherapy or combination therapy
    • Time Frame: Approximately 9 months
  • Percentage of patients receiving nivolumab as second or later line of therapy
    • Time Frame: Approximately 9 months
  • Median treatment duration and range by line and histology
    • Time Frame: Approximately 9 months
  • Rate of permanent and temporary discontinuations
    • Time Frame: Approximately 9 months
  • Reasons for discontinuation of nivolumab
    • Time Frame: Approximately 9 months
  • Reasons for re-challenge of nivolumab
    • Time Frame: Approximately 9 months
  • Objective Response Rate (ORR) as assessed by investigator
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Collaborator
    • Ono Pharmaceutical Co. Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.