A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab

May 25, 2022 updated by: Bristol-Myers Squibb

Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience

This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelburg, Victoria, Australia, 3084
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May 2015 and August 2017 under the Australian Patient Access Program

Description

Inclusion Criteria

  • Adult male or female (≥18 years of age) patients with NSCLC
  • Treated with nivolumab on the Australian PAP
  • Initiated Nivolumab between May 2015 and August 2017
  • Attending clinician agreeable to provide patient data
  • Local institutional ethics requirements satisfied

Exclusion Criteria:

  • Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients taking nivolumab
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to treatment failure (TTF)
Time Frame: Approximately 27 months
Approximately 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response (BOR)
Time Frame: Approximately 27 months
Approximately 27 months
Progression free survival rate (PFSR)
Time Frame: Approximately 27 months
Approximately 27 months
Overall survival rate (OSR)
Time Frame: Approximately 27 months
Approximately 27 months
Incidence of AE's
Time Frame: Approximately 27 months
Approximately 27 months
Incidence of SAE's
Time Frame: Approximately 27 months
Approximately 27 months
Reasons for ceasing treatment
Time Frame: Approximately 27 months
Any of the following: progressive disease, toxicity, patient wishes/preference, doctor decision, death
Approximately 27 months
Incidence of patients with brain metastases
Time Frame: Approximately 27 months
Approximately 27 months
Incidence of re-treatment
Time Frame: Approximately 27 months
Approximately 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

August 12, 2021

Study Completion (Actual)

August 12, 2021

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-8MH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Non-Interventional

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe