Clinical trial · Observational
ProSpecTive sAmpling in dRiver muTation Pulmonary Oncology Patients on Tyrosine Kinase Inhibitors (START-TKI)
proSpecTive sAmpling in dRiver muTation Pulmonary Oncology Patients on Tyrosine Kinase Inhibitors
NCT05221372CI-TRIAL-00056607START-TKIrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liquid Biopsy | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Tyrosine Kinase Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- timeFrame
- 10 years
- description
- 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)
- measure
- Plasma concentrations of the small molecule kinase inhibitor during treatment until progression of disease
- timeFrame
- 10 years
- description
- 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.
Secondary outcomes (6)
- measure
- Time to progression or death under treatment with small molecule kinase inhibitor
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTSteendam CMJ, Veerman GDM, Pruis MA, Atmodimedjo P, Paats MS, van der Leest C, von der Thusen JH, Yick DCY, Oomen-de Hoop E, Koolen SLW, Dinjens WNM, van Schaik RHN, Mathijssen RHJ, Aerts JGJV, Dubbink HJ, Dingemans AC. Plasma Predictive Features in Treating EGFR-Mutated Non-Small Cell Lung Cancer. Cancers (Basel). 2020 Oct 29;12(11):3179. doi: 10.3390/cancers12113179. PMID 33138052
- DERIVEDErnst SM, van Marion R, Atmodimedjo PN, de Jonge E, Mathijssen RHJ, Paats MS, de Bruijn P, Koolen SL, von der Thusen JH, Aerts JGJV, van Schaik RHN, Dubbink HJ, Dingemans AC. Clinical Utility of Circulating Tumor DNA in Patients With Advanced KRASG12C-Mutated NSCLC Treated With Sotorasib. J Thorac Oncol. 2024 Jul;19(7):995-1006. doi: 10.1016/j.jtho.2024.04.007. Epub 2024 Apr 12. PMID 38615940
- DERIVEDErnst SM, Uzun S, Paats MS, van Marion R, Atmodimedjo PN, de Jonge E, van Schaik RHN, Aerts JGJV, von der Thusen JH, Dubbink HJ, Dingemans AC. Efficacy and Tolerability of Osimertinib and Sotorasib Combination Treatment for Osimertinib Resistance Caused by KRAS G12C Mutation: A Report of Two Cases. JCO Precis Oncol. 2023 Sep;7:e2300451. doi: 10.1200/PO.23.00451. PMID 38096473