Non-small Cell Lung CancerNCT07213076
Australian Retrospective Analysis of EGFRm Advanced & Metastatic NSCLC Patients Treated With 1L or 2L Osimertinib.
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in Australia.
Trial summary
This is a retrospective, observational study of treatment patterns and clinical outcomes in Australian EGFRm advanced and metastatic non-small cell lung cancer patients treated with first-line osimertinib or second-line osimertinib. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 350 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2025to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with locally advanced or metastatic NSCLC with an activating EGFR mutation, not amenable to curative surgery or radiotherapy. This study consists of two patient cohorts: 1. L Osimertinib: treatment-naïve for advanced NSCLC and initiated 1L Osimertinib per PBS restrictions. 2. L (T790M+) Osimertinib: previously treated with 1st or 2nd generation EGFR TKIs, confirmed T790M+ EGFRm at disease progression and initiated 2L Osimertinib per PBS restrictions.
Who may be able to join
- Male or female, aged at least 18 years.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy, patients with relapsed/recurrent disease and prior treatment in early-stage setting allowed.
- The tumour harbours an activating EGFR mutation
- Enrolled in the AURORA registry
- Patients must be either:
- treatment-naïve for advanced NSCLC (allowing up to 2-cycles of bridging chemotherapy prior to molecular testing results) and initiated 1L Osimertinib per PBS restrictions from August 2020 to December 2022.
- Previously treated with 1st or 2nd generation EGFR TKIs (gefitinib, erlotinib or afatinib) and confirmed T790M+ EGFRm at disease progression and initiated second-line Osimertinib per PBS restrictions from January 2016 to December 2022.
Who cannot join
- There are no predefined exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of Treatment Patterns and Clinical Outcomes in Australian EGFR Mutant Advanced and Metastatic Non-Small Cell Lung Cancer NSCLC Patients: First-line and Second-line Osimertinib Usage
This is a retrospective, observational study of treatment patterns and clinical outcomes in Australian EGFRm advanced and metastatic non-small cell lung cancer patients treated with first-line osimertinib or second-line osimertinib.
Read the detailed description
This study utilizes secondary data collected as part of the AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA), which is registered on the Australian New Zealand Clinical Trial Registry: ACTRN12625000038493.
Objectives: In stage IIIB-IV patients with EGFRm NSCLC treated with Osimertinib in the 1L or T790M+ 2L setting in Australia:
Primary Objectives: To describe the Osimertinib Time to Treatment Discontinuation (TTD) in the 1L and 2L settings (as separate cohorts).
Secondary Objectives: To describe the real-world progression-free survival (rwPFS), overall survival (OS), time to next treatment (TTNT) after Osimertinib, patient demographics and clinical characteristics, patterns of care (e.g additional therapies received during and after Osimertinib) in 1L and 2L (T790M+) patients (as separate cohorts).
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Discontinuation
up to 5 years follow up for 1L cohort and 9 years follow up for 2 L cohort
Measured: minimum of 24 months follow up
Secondary outcomes (6)
rwPFS
up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Measured: minimum 24 months follow up
OS
up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Measured: 12 and 24 months
time to next treatment (TTNT)
up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Measured: minimum 24 months of follow up
baseline demographic and clinical characteristics
Measured: at baseline
Details of therapies given concurrently with Osimertinib
up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Measured: up to 1 year post study activation
Details of therapies given subsequent to Osimertinib
up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Measured: up to 1 year post study activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start4 Jul 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Responsible party
- Sponsor
- Investigators
- Marliese Alexander, Principal investigator, Peter MacCallum Cancer Centre, AustraliaBen Solomon, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213076
- Sponsor's protocol ID
- D5161R00071
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be requested by researchers, academics, industry, or other individuals/organisations, with each request reviewed for appropriateness on a case-by-case basis by the AURORA Chair and Steering Committee. Data sharing requests to be emailed to: AURORA@petermac.org Diagnostics, Clinical and Outcomes IPD may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Treatment Patterns and Clinical Outcomes in Australian EGFR Mutant Advanced and Metastatic Non-Small Cell Lung Cancer NSCLC Patients: First-line and Second-line Osimertinib Usage
- ClinicalTrials.gov ID
- NCT07213076
- Acronym / sponsor ID
- D5161R00071
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective, observational study of treatment patterns and clinical outcomes in Australian EGFRm advanced and metastatic non-small cell lung cancer patients treated with first-line osimertinib or second-line osimertinib.
Detailed description
This study utilizes secondary data collected as part of the AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA), which is registered on the Australian New Zealand Clinical Trial Registry: ACTRN12625000038493.
Objectives: In stage IIIB-IV patients with EGFRm NSCLC treated with Osimertinib in the 1L or T790M+ 2L setting in Australia:
Primary Objectives: To describe the Osimertinib Time to Treatment Discontinuation (TTD) in the 1L and 2L settings (as separate cohorts).
Secondary Objectives: To describe the real-world progression-free survival (rwPFS), overall survival (OS), time to next treatment (TTNT) after Osimertinib, patient demographics and clinical characteristics, patterns of care (e.g additional therapies received during and after Osimertinib) in 1L and 2L (T790M+) patients (as separate cohorts).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with locally advanced or metastatic NSCLC with an activating EGFR mutation, not amenable to curative surgery or radiotherapy. This study consists of two patient cohorts: 1. L Osimertinib: treatment-naïve for advanced NSCLC and initiated 1L Osimertinib per PBS restrictions. 2. L (T790M+) Osimertinib: previously treated with 1st or 2nd generation EGFR TKIs, confirmed T790M+ EGFRm at disease progression and initiated 2L Osimertinib per PBS restrictions.
Key inclusion criteria (7 listed)
- Male or female, aged at least 18 years.
- Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy, patients with relapsed/recurrent disease and prior treatment in early-stage setting allowed.
- The tumour harbours an activating EGFR mutation
- Enrolled in the AURORA registry
- Patients must be either:
Key exclusion criteria (1 listed)
- There are no predefined exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Treatment Discontinuation
Time frame: minimum of 24 months follow up
up to 5 years follow up for 1L cohort and 9 years follow up for 2 L cohort
6 secondary outcomes
rwPFS
Time frame: minimum 24 months follow up
OS
Time frame: 12 and 24 months
time to next treatment (TTNT)
Time frame: minimum 24 months of follow up
baseline demographic and clinical characteristics
Time frame: at baseline
Details of therapies given concurrently with Osimertinib
Time frame: up to 1 year post study activation
Details of therapies given subsequent to Osimertinib
Time frame: up to 1 year post study activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- AURORA ANZCTR registrationLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data may be requested by researchers, academics, industry, or other individuals/organisations, with each request reviewed for appropriateness on a case-by-case basis by the AURORA Chair and Steering Committee. Data sharing requests to be emailed to: AURORA@petermac.org Diagnostics, Clinical and Outcomes IPD may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marliese Alexander principal investigator
Peter MacCallum Cancer Centre, Australia
Ben Solomon principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Discontinuation (time frame: minimum of 24 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.