Clinical Outcome of Epidermal Growth Factor Receptor mutated (EGFR+) Non-small cell lung cancer (NSCLC) patients with first-line tyrosine kinase inhibitors (TKI) resistance on Osimertinib (CONTROL)

Clinical outcome of advanced EGFR-mutated NSCLC patients who developed acquired resistance to first generation EGFR inhibitors with positive plasma T790M treated with osimertinib in NSW, Australia.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000993392

Acronym

CONTROL

Enrollment

Registered

2017-07-10

Start date

2017-09-01

Completion date

2017-12-31

Last updated

2017-07-17

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

Conditions

None listed

Brief summary

This study aims to evaluate clinical outcomes of patients with non-small cell lung cancer (NSCLC) with specific clinical and tumour mutation characteristics treated with osimertinib in NSW, Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have metastatic EGFR mutated NSCLC with plasma/tumour positivity for T790M, currently taking osimertinib, and were previously treated with first generation EGFR inhibitor (gefitinib/erlotinib). Study details We will perform a retrospective analysis of the clinical outcomes in NSCLC patients. We will follow up on your clinical data (first CT scan results and long term outcome from your treatment) and correlate this with the level of T790M mutation shown in your plasma ctDNA. Participants will not be required to undergo any additional tests beside routine clinical tests requested by their oncologists. It is hoped that this study will add to the currently limited knowledge on the correlation between T790M mutation load (relative allelic frequency) and clinical outcomes.

Interventions

Metastatic EGFR mutated NSCLC patients who developed acquired resistance with a secondary EGFR mutation T790M. These patients were started on osimertinib (80mg daily orally until disease progression/significant toxicities) and clinical outcomes of these patients will be observed (response rate, progression free survival and overall survival). The duration of observation will be a minimum of one year since the start of treatment with osimertinib. Maximum duration of observation will be 3 years fr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Over 18 years old Metastatic EGFR mutated NSCLC Developed acquired resistance to first generation EGFR inhibitor Plasma/Tumour positivity for T790M Started on Osimertinib in second line/subsequent line setting

Exclusion criteria

Early lung cancer Not T790M positive Not on Osimertinib

Outcome results