Clinical trial · Interventional
TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-Sampling
Decentralized Therapeutic Drug Monitoring of Taxanes and ALK Inhibitors in NSCLC: A Real-World Feasibility Study Using the True Dose Capillary Self-Sampling System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study will evaluate whether people with non-small cell lung cancer (NSCLC) can collect small blood samples themselves using a finger-prick sampling kit. Participants will be receiving standard treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The blood samples will be used to measure the amount of cancer medicine in the blood. Most samples will be collected by participants at home and returned to a laboratory for analysis. The study will assess how easy the sampling method is to use, whether the collected samples are suitable for laboratory analysis, and how patients and healthcare professionals experience this way of collecting blood samples. The study will also explore whether measured drug levels are related to side effects, dose changes, treatment delays, or other clinical outcomes. The drug-level results collected in this study will be used for research purposes and will not be used to change participants' cancer treatment. About 80 participants will take part in the study and will be followed for approximately 3 months. The microsampling device is CE-marked and used within its approved use exclusively for research and feasibility evaluation. Study results do not influence ongoing clinical treatment decisions. This study is being conducted as part of Project-COMFORT, a European multi-country initiative aiming to evaluate the feasibility and implementation of PCmS across various populations and healthcare systems.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| True Dose® Capillary Self-Sampling System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Taxane Cohort
- description
- Participants with non-small cell lung cancer receiving standard-of-care treatment with docetaxel or paclitaxel will use the True Dose® capillary self-sampling system for collection of blood samples for therapeutic drug monitoring research. Participants will perform capillary sampling at predefined time points following taxane administration. Study drug concentration results will not be used to guide treatment decisions.
- interventionNames
- Device: True Dose® Capillary Self-Sampling System
- type
- EXPERIMENTAL
- label
- ALK Inhibitor Cohort
- description
- Participants with non-small cell lung cancer receiving standard-of-care treatment with alectinib or lorlatinib will use the True Dose® capillary self-sampling system for collection of blood samples for therapeutic drug monitoring research. Capillary samples will be collected at home in relation to the participant's regular oral treatment. Study drug concentration results will not be used to guide treatment decisions.
- interventionNames
- Device: True Dose® Capillary Self-Sampling System
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age ≥18 years. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Receiving ongoing standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. Able to understand Swedish or English and provide written informed consent. Willing and able to comply with study-required procedures, including blood sample collection. Able to perform capillary self-sampling at home, with or without support from a caregiver or healthcare professional. Access to a stable home or remote environment suitable for sample collection and, where applicable, home nurse visits. Able to participate in the required sample collection and shipping procedures, independently or with support from a family member or caregiver. Exclusion Criteria: Concurrent participation in another interventional study that may affect pharmacokinetics. Severe coagulopathy or another contraindication to capillary blood sampling. Known hypersensitivity to a previously used adhesion system used for sample collection. Any condition that, in the investigator's judgment, would make study participation unsafe or infeasible, including skin infection or another skin condition at the intended sample collection site.
References
Publications (8)
- BACKGROUNDGroenland SL, Geel DR, Janssen JM, de Vries N, Rosing H, Beijnen JH, Burgers JA, Smit EF, Huitema ADR, Steeghs N. Exposure-Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non-Small Cell Lung Cancer Patients. Clin Pharmacol Ther. 2021 Feb;109(2):394-402. doi: 10.1002/cpt.1989. Epub 2020 Aug 19. PMID 32686074
- BACKGROUNDMaass KF, Barfield MD, Ito M, James CA, Kavetska O, Kozinn M, Kumar P, Lepak M, Leuthold LA, Li W, Mikhailov D, Patel S, Perez NL, Jackson Rudd D, Vakkalagadda B, Williams TM, Zha J, Zhang X, Anderson MD. Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality. Clin Transl Sci. 2022 Dec;15(12):2785-2795. doi: 10.1111/cts.13411. Epub 2022 Oct 8. PMID 36129129
- BACKGROUNDKomninos N, De Chiara S, Checa A, Wiklander O, Rydberg P, Hedayati E. Development and evaluation of a novel capillary blood collection method for decentralized therapeutic drug monitoring using the True Dose kit. Sci Rep. 2025 Sep 29;15(1):33331. doi: 10.1038/s41598-025-20951-5. PMID 41023074
- BACKGROUNDCrafoord MT, Hedayati E, Johnsson A. Capillary Blood Self-Sampling for Therapeutic Drug Monitoring: A Mixed-Methods Usability Study of the True Dose(R) Kit. Biomed Res Int. 2025 Jul 9;2025:9973081. doi: 10.1155/bmri/9973081. eCollection 2025. PMID 40678388
- BACKGROUNDMc Laughlin AM, Schmulenson E, Teplytska O, Zimmermann S, Opitz P, Groenland SL, Huitema ADR, Steeghs N, Muller L, Fuxius S, Illerhaus G, Joerger M, Mayer F, Fuhr U, Holdenrieder S, Hempel G, Scherf-Clavel O, Jaehde U, Kloft C, For The On-Target Study Consortium. Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol. Cancers (Basel). 2021 Dec 14;13(24):6281. doi: 10.3390/cancers13246281. PMID 34944899
- BACKGROUNDKicken MP, Deenen MJ, van der Wekken AJ, van den Borne BEEM, van den Heuvel MM, Ter Heine R. Opportunities for Precision Dosing of Cytotoxic Drugs in Non-Small Cell Lung Cancer: Bridging the Gap in Precision Medicine. Clin Pharmacokinet. 2025 Apr;64(4):511-531. doi: 10.1007/s40262-025-01492-6. Epub 2025 Mar 5.