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NCT03804554 Clinical Trial

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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03804554
Other study ID # CA209-8MH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2018
Est. completion date August 12, 2021

Study information
Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 503
Est. completion date August 12, 2021
Est. primary completion date August 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Australia Local Institution Heidelburg Victoria

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

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