Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000106831
Ethics application status
Approved
Date submitted
30/11/2020
Date registered
2/02/2021
Date last updated
13/04/2022
Date data sharing statement initially provided
2/02/2021
Date results information initially provided
13/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
AVAL: Australian Vinorelbine use in Advanced Lung cancer
Scientific title
AVAL: Australian Vinorelbine use in Advanced Lung cancer
Secondary ID [1] 302905 0
Not Applicable
Universal Trial Number (UTN)
Not Applicable
Trial acronym
AVAL
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
Metastatic Lung Cancer 319917 0
Condition category
Condition code
Cancer 317859 317859 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
AVAL is a secondary data use, non interventional study that aims to describe the clinical and tumour characteristics and, treatment details of patients with metastatic non-small cell lung cancer, who have received Vinorelbine chemotherapy in the post immunotherapy setting. Data will be collected at single time point from participating Australian public hospitals and private practice from 1st Jan 2020 to 31 Dec 2021.
Intervention code [1] 319191 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325869 0
Tumour histology and molecular subtypes of patients with metastatic NSCLC lung cancer that received Vinorelbine assessed via the patient medical record.
Timepoint [1] 325869 0
Participants will enrol over a 1 year period. Data will be collected at a single time point
Primary outcome [2] 326161 0
Initial treatment details of patients with metastatic NSCLC lung cancer that received Vinorelbine will be assessed from the patient medical records.
Timepoint [2] 326161 0
Participants will enrol over a 1 year period. Data will be collected at a single time point
Secondary outcome [1] 390292 0
Treatment duration of patients with metastatic NSCLC lung cancer that received Vinorelbine assessed from patient medical records.
Timepoint [1] 390292 0
Participants will enrol over a 1 year period. Data will be collected at a single time point
Secondary outcome [2] 390293 0
Vinorelbine dosage details of patients with metastatic NSCLC lung cancer assessed via patient records.
Timepoint [2] 390293 0
Participants will enrol over a 1 year period. Data will be collected at a single time point
Secondary outcome [3] 391238 0
Toxicities associated in metastatic NSCLC lung cancer patients receiving Vinorelbine assessed from patient medical records,
Timepoint [3] 391238 0
Participants will enrol over a 1 year period. Data will be collected at a single time point
Secondary outcome [4] 391239 0
Overall survival of metastatic NCLCL lung cancer patients treated with Vinorelbine assessed via patient medical records.
Timepoint [4] 391239 0
Participants will enrol over a 1 year period. Data will be collected at a single time point

Eligibility
Key inclusion criteria
1. Patients receiving Vinorelbine chemotherapy for metastatic non small cell lung cancer post immunotherapy.
2. Treating clinician is able to provide comprehensive clinicopathological and treatment data.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The aim of this study is to better understand the treatment and outcomes of patients with metastatic non small cell lung cancer in routine clinical practice in Australia. As such, there is no formal statistical plan. There is intention to compare the patients characteristics using descriptive statistics. Chi-square and Fisher’s test will be used to test associations. It is anticipated that a sample size of 20 is sufficient to achieve the main objectives of this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2021
Actual
2/07/2021
Date of last participant enrolment
Anticipated
Actual
20/12/2021
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
20
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 18121 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 18122 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 18124 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 32114 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 32115 0
2298 - Waratah
Recruitment postcode(s) [3] 32117 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 307325 0
Commercial sector/Industry
Name [1] 307325 0
Pierre Fabre
Country [1] 307325 0
Australia
Primary sponsor type
Other
Name
The Walter Eliza Hall Institute for Medical Research
Address
1G Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 307964 0
None
Name [1] 307964 0
Address [1] 307964 0
Country [1] 307964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307415 0
Melbourne Health HREC
Ethics committee address [1] 307415 0
Office for Research Level 2 South West 300 Grattan Street Parkville, VIC 3050
Ethics committee country [1] 307415 0
Australia
Date submitted for ethics approval [1] 307415 0
28/10/2020
Approval date [1] 307415 0
27/11/2020
Ethics approval number [1] 307415 0
HREC/69558/MH-2020

Summary
Brief summary
The purpose of this study is to review the use of Vinorelbine as a chemotherapy treatment option in patients post immunotherapy for metastatic non-small cell lung cancer (NSCLC).

Who is it for?
You may be eligible for this study if you, have received immunotherapy for metastatic NSCLC and are a patient at one of the participating sites.

Study details
Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. Enrolled participants will have clinical data collected at one time point from their medical record. Data will be collected on the tolerability and duration of Vinorelbine chemotherapy when used following immunotherapy treatment in patients with metastatic NSCLC.

It is hoped this research will offer insight into the use of Vinorelbine as a potentially beneficial treatment option for patients with metastatic NSCLC in the post immunotherapy setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107158 0
Prof Peter Gibbs
Address 107158 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 107158 0
Australia
Phone 107158 0
+61 3 9345 2555
Fax 107158 0
Email 107158 0
[email protected]
Contact person for public queries
Name 107159 0
Dr Ben Markman
Address 107159 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 107159 0
Australia
Phone 107159 0
+61 3 9345 2555
Fax 107159 0
Email 107159 0
[email protected]
Contact person for scientific queries
Name 107160 0
Dr Ben Markman
Address 107160 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 107160 0
Australia
Phone 107160 0
+61 3 9345 2555
Fax 107160 0
Email 107160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
AVAL is non-interventional study of patients in Australia who receive treatment with Vinorelbine chemotherapy in the post immunotherapy setting of metastatic non-small cell lung cancer (NSCLC). Data from participating sites will be combined for analysis. Therefore, IPD will not be relevant for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.