Status:
RECRUITING
Australian Retrospective Analysis of EGFRm Advanced & Metastatic NSCLC Patients Treated With 1L or 2L Osimertinib.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Peter MacCallum Cancer Centre, Australia
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Brief 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 osimert...
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 Tri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- There are no predefined exclusion criteria.
Key Trial Info
Start Date :
July 4 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 10 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07213076
Start Date
July 4 2025
End Date
November 10 2025
Last Update
October 8 2025
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000