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

10 september 2026 bijgewerkt door: Elham Hedayati, Karolinska Institutet

Decentralized Therapeutic Drug Monitoring of Taxanes and ALK Inhibitors in NSCLC: A Real-World Feasibility Study Using the True Dose Capillary Self-Sampling System

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Zweden
      • Stockholm, Zweden, 17166
        • Institution of Oncology-Pathology
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Taxane Cohort
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.
Apparaat: True Dose® Capillary Self-Sampling System
The True Dose® capillary self-sampling system is a patient-centric microsampling system that enables collection of approximately 50 µL of capillary whole blood using a finger prick. Participants are trained to perform capillary blood collection, primarily at home, and samples are returned by mail for laboratory analysis of drug concentrations. The study evaluates the feasibility, usability, and sample suitability of decentralized capillary self-sampling for therapeutic drug monitoring. Results from study-specific drug concentration measurements will be used for research purposes and will not be used to guide participants' cancer treatment.
Experimenteel: ALK Inhibitor Cohort
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.
Apparaat: True Dose® Capillary Self-Sampling System
The True Dose® capillary self-sampling system is a patient-centric microsampling system that enables collection of approximately 50 µL of capillary whole blood using a finger prick. Participants are trained to perform capillary blood collection, primarily at home, and samples are returned by mail for laboratory analysis of drug concentrations. The study evaluates the feasibility, usability, and sample suitability of decentralized capillary self-sampling for therapeutic drug monitoring. Results from study-specific drug concentration measurements will be used for research purposes and will not be used to guide participants' cancer treatment.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
Tijdsspanne: From first scheduled home sampling until completion of the sampling period, approximately 1 month.
Proportion of participants who successfully complete at least one scheduled home capillary self-sampling procedure resulting in a laboratory-approved sample and a reportable drug concentration. Success is defined as completion of all of the following: (1) participant performs the capillary self-collection within the predefined sampling window; (2) the sample is received by the laboratory; (3) the sample meets predefined laboratory suitability criteria, including sufficient sample volume and acceptable sample integrity; and (4) the relevant drug concentration can be successfully quantified using the validated analytical method. The outcome will be reported as the number and percentage of participants meeting all criteria.
From first scheduled home sampling until completion of the sampling period, approximately 1 month.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Usability and Acceptability of Capillary Self-Sampling
Tijdsspanne: Through study completion, approximately 3 months

Participant-rated ease of performing capillary self-sampling, assessed using the study-specific patient questionnaire. Participants rate the statement "It was easy to take the blood sample myself" on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater perceived ease of use. Results will be reported as the distribution of responses and/or median and interquartile range.

Participant acceptability of decentralized capillary self-sampling, assessed using the study-specific patient questionnaire on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate greater acceptability. The predefined acceptability item will assess willingness to use home capillary self-sampling as part of future cancer care.
Through study completion, approximately 3 months
Need for Assistance With Capillary Self-Sampling
Tijdsspanne: Through study completion, approximately 3 months
Proportion of participants who require assistance or report difficulty when using the capillary self-sampling system. This outcome will assess whether the training materials and instructions are sufficient to support participants in performing the sampling procedure.
Through study completion, approximately 3 months
Laboratory Sample Suitability
Tijdsspanne: Through study completion, approximately 3 months
Number and proportion of returned capillary blood samples meeting all predefined laboratory suitability criteria for drug concentration analysis. A sample will be classified as suitable when sufficient sample volume is available, sample integrity is acceptable, and the sample can proceed to quantitative analysis according to the predefined laboratory procedures. The denominator will be all capillary samples received by the laboratory.
Through study completion, approximately 3 months
Barriers and Facilitators to Implementation of Capillary Self-Sampling
Tijdsspanne: Through study completion, approximately 3 months
Barriers and facilitators to implementation of patient-centric microsampling will be explored through semi-structured focus groups and/or interviews with patients and healthcare professionals. The evaluation will address uptake and adherence, trust, usability and acceptability, training needs, effects on clinical workflow and communication, and patient autonomy. Interviews will be audio-recorded, transcribed verbatim, and analyzed using qualitative content analysis.
Through study completion, approximately 3 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Capillary Blood Concentration of Docetaxel
Tijdsspanne: At predefined pharmacokinetic sampling time points during docetaxel treatment, through study completion, approximately 3 months.
Docetaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method. Concentrations will be reported in ng/mL.
At predefined pharmacokinetic sampling time points during docetaxel treatment, through study completion, approximately 3 months.
Capillary Blood Concentration of Paclitaxel
Tijdsspanne: At predefined pharmacokinetic sampling time points during paclitaxel treatment, through study completion, approximately 3 months.
Paclitaxel concentration measured in capillary blood at predefined sampling time points using the validated quantitative analytical method. Concentrations will be reported in ng/mL.
At predefined pharmacokinetic sampling time points during paclitaxel treatment, through study completion, approximately 3 months.
Capillary Blood Trough Concentration (Cmin) of Alectinib
Tijdsspanne: At predefined steady-state sampling during alectinib treatment, through study completion, approximately 3 months.
lectinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point. Concentrations will be reported in ng/mL.
At predefined steady-state sampling during alectinib treatment, through study completion, approximately 3 months.
Capillary Blood Trough Concentration (Cmin) of Lorlatinib
Tijdsspanne: At predefined steady-state sampling during lorlatinib treatment, through study completion, approximately 3 months.
Lorlatinib trough concentration (Cmin) measured in capillary blood at the predefined steady-state sampling time point. Concentrations will be reported in ng/mL.
At predefined steady-state sampling during lorlatinib treatment, through study completion, approximately 3 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Medewerkers

Vinnova
Project-COMFORT
Stockholm School of Economics Institute for Research (SIR)
ALK Positive Sverige, Sweden
True Dose AB

Onderzoekers

  • Hoofdonderzoeker: Simon Ekman, Professor, MD, PhD, Karolinska Institutet

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2029

Studieregistratiedata

Eerst ingediend

28 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Dnr 2026-01638-01

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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