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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Time to Treatment Discontinuation
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 Criteria
- •There are no predefined exclusion criteria.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- rwPFS(minimum 24 months follow up)
- OS(12 and 24 months)
- time to next treatment (TTNT)(minimum 24 months of follow up)
- baseline demographic and clinical characteristics(at baseline)
- Details of therapies given concurrently with Osimertinib(up to 1 year post study activation)
- Details of therapies given subsequent to Osimertinib(up to 1 year post study activation)