TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-Sampling

This prospective, non-interventional feasibility and implementation study evaluates decentralized therapeutic drug monitoring (TDM) using capillary self-sampling in adults with non-small cell lung cancer (NSCLC) receiving standard-of-care treatment with docetaxel, paclitaxel, alectinib, or lorlatinib. The study focuses on the feasibility, usability, and implementation of patient-centric microsampling in routine oncology care.

Participants will be trained to collect a small capillary whole-blood sample using a finger prick. Samples will be collected mainly at home and returned by mail for laboratory analysis. Sampling schedules are adapted to the treatment received. For participants receiving taxanes, capillary samples are collected at defined time points after infusion. For participants receiving ALK inhibitors, samples are collected at home in relation to the scheduled oral dose.

The primary focus of the study is whether participants can successfully perform capillary self-sampling and whether the returned samples are suitable for laboratory analysis. Participant experience, usability, need for assistance, and practical aspects of integrating home-based sampling into oncology care will also be evaluated. Qualitative interviews or focus groups with patients and healthcare professionals will explore barriers and facilitators to implementation and the potential impact of decentralized sampling on clinical workflows.

Drug concentrations will be measured for research purposes. Exploratory analyses will examine associations between drug exposure and clinical measures such as treatment-related toxicity, dose modifications or delays, hospital visits, and clinical response when available. In participants with both capillary and venous samples, the relationship between concentrations measured using the two sampling methods may also be evaluated.

Participants will continue to receive their prescribed cancer treatment according to standard clinical practice. The study does not introduce an investigational medicinal product, randomize participants, or require treatment changes based on study measurements. Drug concentration results obtained through capillary self-sampling will not be used to guide treatment decisions during the study.

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.