Blood based testing in treatment monitoring for EGFR-mutated Non-Small Cell Lung Cancer

Longitudinal follow up study to assess utility of blood based testing using circulating tumour cells (CTC) and circulating tumour DNA (ctDNA) in treatment monitoring for patients with advanced EGFR-mutated Non-small cell lung cancer (NSCLC)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000985381

Enrollment

Registered

2017-07-10

Start date

2016-02-01

Completion date

2017-12-29

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 the utility of blood based testing ('liquid biopsy') in the management of patients with Epidermal Growth Factor Receptor mutated (EGFR+) non-small cell lung cancer (NSCLC) Who is it for? You may be eligible to join this study if you are aged 18 years or above and have metastatic EGFR+ NSCLC and will be starting treatment with EGFR inhibitors. Study details We will perform a prospective follow up study to investigate if liquid biopsy could be used to monitor the treatment response and detect treatment resistance in EGFR+ NSCLC patients. Participants will be required to have blood collected (3 tubes of 9ml blood sample each time) before they start treatment, 1 month into treatment, 3 months into treatment and 6 months into treatment. We will be analysing cancer cells and cancer DNA which may be found in the blood (ie. circulating cancer cells/CTC and circulating tumour DNA/ctDNA). It is hoped that this study will add to the currently limited knowledge on whether we could use CTC/ctDNA to predict the effectiveness of a treatment, as well as clinical outcomes for patients. This study will also hopefully answer the question of whether common mutations and novel mutations causing treatment resistance could be detected in liquid biopsy, and therefore could replace the more invasive tissue biopsy in the future to diagnose and monitor treatment response for patients with EGFR+ lung cancer.

Interventions

Blood samples collected for CTC and CtDNA isolation before patients start treatment with EGFR inhibitor (Gefitinib 250mg orally once daily or Erlotinib 150mg orally once daily), blood samples were also collected at month 1, 3, 6, 12 and at disease progression. CTC will be enumerated and individually picked for mutational analyses. CtDNA will be extracted from plasma at all the timepoints for mutational analyses. Treatment with EGFR inhibitor will be continued until disease progression or unacce

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Above 18 years old New diagnosis of metastatic EGFR mutated NSCLC and will be started on first generation EGFR inhibitors Compliance with blood collection at pre-specified time points Compliance with EGFR inhibitors

Exclusion criteria

Early stage disease Non-compliance to treatment or blood collection

Outcome results