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Trial registered on ANZCTR


Registration number
ACTRN12621001231831
Ethics application status
Approved
Date submitted
9/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence and clinical outcomes of KRASG12C mutated advanced lung cancer patients in Australia
Scientific title
Prevalence and clinical outcomes of KRASG12C mutated advanced lung cancer patients in Australia
Secondary ID [1] 304991 0
None
Universal Trial Number (UTN)
Not applicable
Trial acronym
None
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 323146 0
Condition category
Condition code
Cancer 320720 320720 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a secondary data use, non interventional study that aims to determine the prevalence of KRASG12C mutated advanced Non Small Cell Lung Cancer (NSCLC) patients and describe the clinical and tumour characteristics, and treatment outcomes for these patients. Data will be collected retrospectively at a single time point from participating Australian public hospitals and private practice from patients newly diagnosed with advanced NSCLC between 1 Jan 2018 to 31 Dec 2019. There will be no additional testing or imaging required above what has been done as part of the patients routine standard of care.
Intervention code [1] 321381 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328539 0
To determine the prevalence of KRASG12C mutated advanced NSCLC by screening newly diagnosed advanced NSCLC participants between Jan 2018 and Dec 2019 with KRASG12C molecular testing performed.
Timepoint [1] 328539 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Primary outcome [2] 328540 0
To determine the composite clinical characteristics of KRASG12C mutated NSCLC participants by assessing demographic factors including; gender, ethnicity, age, smoking status, ECOG at diagnosis and Charlson Comorbidity Index
Timepoint [2] 328540 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Primary outcome [3] 328742 0
To assess the composite disease specific characteristics of KRASG12 mutant NSCLC participants by assessing stage of NSCLC (as determined by the eighth edition of the TNM staging), number of sites of metastases, and the reported histology type: Adenocarcinoma, adenosquamous carcinoma, large cell carcinoma and squamous cell carcinoma, NSCLC NOS (not otherwise specified).
Timepoint [3] 328742 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [1] 399361 0
Primary Outcome 4.
To determine the real world treatment outcomes in KRASG12C mutated advanced NSCLC participants by assessing progression free survival.

Timepoint [1] 399361 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [2] 399362 0
To describe the diagnostic pathway utilised for biomarker testing of advanced NSLCL participants with reported KRASG12C mutation, biomarker wildtype, or other KRAS mutations, by assessing the type of platform/molecular test used and the proportion of centres performing next generation sequencing.
Timepoint [2] 399362 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [3] 400231 0
To determine the treatment characteristics of KRASG12C mutant NSCLC participants, by assessing the number of lines of active systemic anti-cancer therapy and use of immune therapy.
Timepoint [3] 400231 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [4] 400232 0
To determine the Overall Survival (OS) of KRASG12C mutant NSCLC participants as measured from the date of diagnosis for advanced NSCLC to date of death (censored to last follow up).
Timepoint [4] 400232 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [5] 400233 0
To determine the Progression free survival (PFS) of KRASG12C mutant NSCLC participants by assessing progression after first and second line systemic anti-cancer therapies.

Timepoint [5] 400233 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.
Secondary outcome [6] 400869 0
Primary Outcome 5.
To determine the real world treatment outcomes in KRASG12C mutated advanced NSCLC participants by assessing their overall survival.
Timepoint [6] 400869 0
Retrospective data will be collected from the participants medical record from Jan 2018 to Dec 2019 at a single time point.

Eligibility
Key inclusion criteria
1. Patients with histologically (or cytologically) confirmed advanced non-small cell lung cancer who are diagnosed and referred to a participating centre for consideration of systemic treatment between 1 January 2018 - 31 December 2019
2. Centres that are routinely requesting KRASG12C testing or a panel that includes KRASG12C testing. Molecular data including the presence or absence of KRASG12C mutation must be available
3. Clear documentation of date of tissue diagnosis of advanced NSCLC, clinical presentation, medical co-morbidities, performance status, treatment options delivered, response assessment, therapy duration, reason for treatment discontinuation, site(s) of disease progression and survival data.
4. Patients with any site of metastatic disease including brain metastases
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who were initially diagnosed and referred for systemic treatment before 1 January 2018
2. Patients with absent key tumour, treatment or outcome data
3. Patients in whom KRAS status is unknown

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The aim of this study is to determine incidence and clinical outcomes of KRASG12C mutated advanced (unresectable Stage IIIb/IIIc and Stage IV) non-small cell lung cancer patients in Australia. As all analyses are descriptive, no hypothesis testing is planned. There is intention to compare the patient characteristics using descriptive analyses. Kaplan-Meier analysis will be used for PFS and OS analysis. If sufficient numbers are obtained, analyses will also be presented by subgroups age, gender, smoking status, ethnicity, CCI score, number of sites of metastases, presence or absence of brain metastases, number of line of therapies and type of therapies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 20154 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 20155 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 20156 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [4] 20157 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 20158 0
Royal Hobart Hospital - Hobart
Recruitment hospital [6] 20159 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 20160 0
The Canberra Hospital - Garran
Recruitment hospital [8] 20161 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 34884 0
3000 - Melbourne
Recruitment postcode(s) [2] 34885 0
2065 - St Leonards
Recruitment postcode(s) [3] 34886 0
2050 - Camperdown
Recruitment postcode(s) [4] 34887 0
5011 - Woodville
Recruitment postcode(s) [5] 34888 0
7000 - Hobart
Recruitment postcode(s) [6] 34889 0
4029 - Herston
Recruitment postcode(s) [7] 34890 0
2605 - Garran
Recruitment postcode(s) [8] 34891 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 309375 0
Commercial sector/Industry
Name [1] 309375 0
Amgen Australia
Address [1] 309375 0
123 Epping Rd, Macquarie Park, NSW 2113
Country [1] 309375 0
Australia
Primary sponsor type
Other
Name
The Walter and Eliza Hall Institute for Medical Research
Address
1G Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 310347 0
None
Name [1] 310347 0
Address [1] 310347 0
Country [1] 310347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309191 0
Melbourne Health HREC
Ethics committee address [1] 309191 0
Royal Melbourne Hospital. Office for Research, Level 2 South West, 300 Grattan Street, Parkville, VIC 3050
Ethics committee country [1] 309191 0
Australia
Date submitted for ethics approval [1] 309191 0
25/05/2021
Approval date [1] 309191 0
11/06/2021
Ethics approval number [1] 309191 0
HREC/75425/MH-2021

Summary
Brief summary
The purpose of this study is to determine incidence and clinical outcomes of KRASG12C mutated advanced non-small cell lung cancer patients in Australian cancer therapy centres.

Who is it for
You may be eligible for this study if you, were diagnosed with advanced NSCLC with the presence of a KRAS G12C mutation between Jan 2018 and Dec 201 , 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 from one time point from their medical record. Data captured will include patient characteristics, disease characteristics, surgical and or drug treatments administered, survival, and treatment outcomes. Data will be collected at a single point by study personnel from the patient medical record.

This study aims to help Oncologist better understand the incidence, demographics, disease characteristics and survival outcomes of KRASG12C mutated advanced NSCLC in Australia. This may ultimately lead to improved standard of care practices which will improve patient outcomes.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113290 0
Prof Peter Gibbs
Address 113290 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Pde, Parkville, VIC 3052
Country 113290 0
Australia
Phone 113290 0
+61 3 9345 2897
Fax 113290 0
Email 113290 0
peter.gibbs@mh.org.au
Contact person for public queries
Name 113291 0
Dr Ben Markman
Address 113291 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Pde, Parkville, VIC 3052
Country 113291 0
Australia
Phone 113291 0
+61 3 9345 2555
Fax 113291 0
Email 113291 0
markman.b@wehi.edu.au
Contact person for scientific queries
Name 113292 0
Dr Ben Markman
Address 113292 0
The Walter and Eliza Hall Institute of Medical Research, 1G Royal Pde, Parkville, VIC 3052
Country 113292 0
Australia
Phone 113292 0
+61 3 9345 2555
Fax 113292 0
Email 113292 0
markman.b@wehi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a non-interventional cohort study of advanced KRAS G12C mutated non small cell lung cancer (NSCLC) patients diagnosed and treated between 1st January 2018 and 31st December 2019 in Australian cancer therapy centres. The data from participating sites will be combined for analysis. Therefore, IPD will be irrelevant for this study.
What supporting documents are/will be available?
No other documents available
Summary results
No Results