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Completed

NCT Number: NCT07213076

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Melbourne, Victoria, 3000, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. rwPFS

    Time frame: minimum 24 months follow up

    up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort

  2. OS

    Time frame: 12 and 24 months

    up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort

  3. time to next treatment (TTNT)

    Time frame: minimum 24 months of follow up

    up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort

  4. baseline demographic and clinical characteristics

    Time frame: at baseline

  5. Details of therapies given concurrently with Osimertinib

    Time frame: up to 1 year post study activation

    up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort

  6. Details of therapies given subsequent to Osimertinib

    Time frame: up to 1 year post study activation

    up to 5 years follow up for 1L cohort and 9 years follow up for 2L cohort

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Peter MacCallum Cancer Centre, Australia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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