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

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ClinicalTrials.gov Identifier: NCT03273790
Recruitment Status : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Other: Non-interventional

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Group/Cohort Intervention/treatment
NSCLC patients
Initiated Nivolumab treatment at least once from 01 Apr. 2016 through 31 Dec. 2016
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  1. Description of clinical usage of nivolumab in previously treated NSCLC patients [ Time Frame: Approximately 9 months ]
  2. Overall Survival (OS) [ Time Frame: Approximately 9 months ]
    Measured from time of initial diagnosis and treatment with nivolumab until date of death

  3. 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 Outcome Measures :
  1. Percentage of patients receiving bi-weekly nivolumab [ Time Frame: Approximately 9 months ]
  2. Percentage of patients receiving monotherapy or combination therapy [ Time Frame: Approximately 9 months ]
  3. Percentage of patients receiving nivolumab as second or later line of therapy [ Time Frame: Approximately 9 months ]
  4. Median treatment duration and range by line and histology [ Time Frame: Approximately 9 months ]
  5. Rate of permanent and temporary discontinuations [ Time Frame: Approximately 9 months ]
  6. Reasons for discontinuation of nivolumab [ Time Frame: Approximately 9 months ]
  7. Reasons for re-challenge of nivolumab [ Time Frame: Approximately 9 months ]
  8. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously treated advanced/metastatic NSCLC patients treated with nivolumab in Japan.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273790


Locations
Japan
Local Institution
Minato-ku, Tokyo, Japan, 1050001
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03273790     History of Changes
Other Study ID Numbers: CA209-9CR
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents