Health TrialsbyHealthPanel

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

ConditionsNon Small Cell Lung CancerLiquid BiopsyTyrosine Kinase Inhibitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to draw blood for study purposes

Trial population

Adult patients with non-small cell lung cancer treated with a tyrosine kinase inhibitor

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

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)

Time frame
10 years
2

Plasma concentrations of the small molecule kinase inhibitor during treatment until progression of disease

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.

Time frame
10 years

Secondary outcomes

1

Time to progression or death under treatment with small molecule kinase inhibitor

Time to progression or death is defined as time from start of the small molecule kinase inhibitor to radiological progression (according to measurements conform RECIST v.1.1) or death.

Time frame
10 years
2

Overall survival

Defined as time from start of the small molecule kinase inhibitor to death.

Time frame
10 years
3

Pharmacokinetics of intratumoral small molecule kinase inhibitors

Measuring intratumoral concentrations of small molecule kinase inhibitors on tumor biopsy taken as part of regular care

Time frame
10 years
4

Correlation of mutation status in blood to (re)biopsy specimen results performed for standard-of-care.

Concordance of detection of tumor mutations will be evaluated between ddPCR, NGS in blood, and NGS in tissue samples when available

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Source ClinicalTrials.gov
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