Australian Retrospective Analysis of EGFRm Advanced & Metastatic NSCLC Patients Treated With 1L or 2L Osimertinib.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07213076

Enrollment

350

Registered

2025-10-08

Start date

2025-07-04

Completion date

2025-11-10

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Australia

Contacts

PRINCIPAL_INVESTIGATORMarliese Alexander

Peter MacCallum Cancer Centre, Australia

PRINCIPAL_INVESTIGATORBen Solomon