Studieoverzicht

Study name: START-TKI: Prospective sampling in lung cancer patients with driver mutations treated with tyrosine kinase inhibitors

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	Amphia	Enrollment	Recruiting
Therapy line	First line (1L)Later line (≥2L)
Design	Observational study with collection of extra blood tubes, 24 mL, during already planned blood sampling. The additional risk of taking extra blood during routine treatment is considered negligible.
Intervention	To collect blood from patients treated with TKI for mutation research, determine the clinically relevant cutoff value for progression due to therapy resistance, and perform pharmacokinetic analysis.
Key outcome parameters	Primary outcome measures: plasma levels of resistance mutations and pharmacokinetics over time and at progression. Secondary outcome measures: primary mutation levels, time to progression, correlation between different mutation tests and biopsies according to standard care, plus TKI concentration, smoking status, and BMI.
Key inclusion criteria	At least 18 years old Able to understand the information provided and give informed consent Locally advanced or metastatic lung carcinoma with an oncogenic driver mutation Treatment with a tyrosine kinase inhibitor according to standard care
Key exclusion criteria	Extra blood sampling for research not possible
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