Australian Retrospective Analysis of EGFRm Advanced & Metastatic NSCLC Patients Treated With 1L or 2L Osimertinib.
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT07213076
- Lead Sponsor
- AstraZeneca
- 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 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
-
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
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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.
There are no predefined exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Treatment Discontinuation minimum of 24 months follow up up to 5 years follow up for 1L cohort and 9 years follow up for 2 L cohort
- Secondary Outcome Measures
Name Time Method rwPFS minimum 24 months follow up up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
OS 12 and 24 months up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
time to next treatment (TTNT) minimum 24 months of follow up up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
baseline demographic and clinical characteristics at baseline Details of therapies given concurrently with Osimertinib up to 1 year post study activation up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Details of therapies given subsequent to Osimertinib up to 1 year post study activation up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort
Trial Locations
- Locations (1)
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre🇦🇺Melbourne, Victoria, Australia