ProSpecTive sAmpling in dRiver muTation Pulmonary Oncology Patients on Tyrosine Kinase Inhibitors (START-TKI)

NCT05221372 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Erasmus Medical Center

Phase

Observational

Started

2017-02-02

Last updated

2022-02-18

Condition(s) studied

Non Small Cell Lung CancerLiquid BiopsyTyrosine Kinase Inhibitor

Study summary

The study is perfomed with adult patients with non-small cell lung cancer treated with tyrosine kinase inhibitor. The objective is to collect repeated samples of blood from patients (starting) on a tyrosine kinase inhibitor, for liquid mutation testing, and pharmacokinetic analysis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years * Able to understand the written informed and able to give informed consent * Locally advanced or metastatic NSCLC with oncogenic driver mutation * Treatment with TKI according to standard of care Exclusion Criteria: * Unable to draw blood for study purposes

Primary outcome measure(s)

Relative presence of primary mutation and resistance mutations in plasma levels under treatment of a small molecule kinase inhibitor until progression of disease measured in variant allele frequency — 10 years
Describing the plasma levels of primary mutations and resistance mutations under treatment by sequentially measuring cell free tumor DNA. Different techniques will be used for the plasma mutation detection (ddPCR and NGS)
Plasma concentrations of the small molecule kinase inhibitor during treatment until progression of disease — 10 years
Describing the plasma concentrations over time during treatment with a small molecule kinase inhibitor by sequentially measuring mean concentrations of the small molecule kinase inhibitor.

Trial sites (1)

Facility	City	Region	Status
Erasmus MC	Rotterdam	Netherlands	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05221372 on ClinicalTrials.gov ↗ ← All trials in the Netherlands