NCT07823725Not yet recruiting
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 · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Karolinska Institutet
- Diseases
- Lung cancer
- NCT number
- NCT07823725
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Oct 2026 to the primary completion date, 1 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institution of Oncology-Pathology Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Karolinska Univeristy Hospital, Theme Cancer, Lung Cancer Department Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.