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

NCT07213076 | Completed

• 1 other identifier: D5161R00071
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Treatment Discontinuation

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

  minimum of 24 months follow up

Secondary Outcomes (6)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (1)

Research Site

Melbourne, Victoria, 3000, Australia

Location

Related Links

• AURORA ANZCTR registration

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marliese Alexander

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• Ben Solomon

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: July 4, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the study is complete and reported.
• Access Criteria: Each request reviewed for appropriateness on a case-by-case basis by the AURORA Chair and Steering Committee.

Locations

AU (1)