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.

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).

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 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 Criteria:

There are no predefined exclusion criteria.

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.

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.

Once the study is complete and reported.

Each request reviewed for appropriateness on a case-by-case basis by the AURORA Chair and Steering Committee.