Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03804554




Registration number
NCT03804554
Ethics application status
Date submitted
12/11/2018
Date registered
15/01/2019
Date last updated
27/05/2022

Titles & IDs
Public title
A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab
Scientific title
Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience
Secondary ID [1] 0 0
CA209-8MH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-Interventional

Patients taking nivolumab -


Other interventions: Non-Interventional
Non-Interventional
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure (TTF)
Timepoint [1] 0 0
Approximately 27 months
Secondary outcome [1] 0 0
Best overall response (BOR)
Timepoint [1] 0 0
Approximately 27 months
Secondary outcome [2] 0 0
Progression free survival rate (PFSR)
Timepoint [2] 0 0
Approximately 27 months
Secondary outcome [3] 0 0
Overall survival rate (OSR)
Timepoint [3] 0 0
Approximately 27 months
Secondary outcome [4] 0 0
Incidence of AE's
Timepoint [4] 0 0
Approximately 27 months
Secondary outcome [5] 0 0
Incidence of SAE's
Timepoint [5] 0 0
Approximately 27 months
Secondary outcome [6] 0 0
Reasons for ceasing treatment
Timepoint [6] 0 0
Approximately 27 months
Secondary outcome [7] 0 0
Incidence of patients with brain metastases
Timepoint [7] 0 0
Approximately 27 months
Secondary outcome [8] 0 0
Incidence of re-treatment
Timepoint [8] 0 0
Approximately 27 months

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/08/2021
Sample size
Target
Accrual to date
Final
503
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Heidelburg
Recruitment postcode(s) [1] 0 0
3084 - Heidelburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT03804554
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03804554