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Completed

NCT Number: NCT03273790

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

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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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Minato-ku, Tokyo, 1050001, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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