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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03804554