Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)TD-LungNCT07823725
TailorDose Lung: Decentralized TDM of Taxanes and ALK Inhibitors Using Capillary Self-Sampling
A study testing True Dose® Capillary Self-Sampling System in people with Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)
- What is being tested?
- True Dose® Capillary Self-Sampling System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elin Backman Stålnacke, Speciliased Nurse in Oncology contact
Sweden2 sites
Institution of Oncology-Pathology
Stockholm, 17166
Elham Hedayati, MD phD, +46709261035, elham.hedayati@ki.se
Karolinska Univeristy Hospital, Theme Cancer, Lung Cancer Department
Stockholm, 17176
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- True Dose® Capillary Self-Sampling System
- Keywords
- Therapeutic drug monitoring, Patient-centric microsampling, Capillary self-sampling, Precision dosing, Docetaxel, Alectinib, Lorlatinib, ALK inhibitors, Taxanes, Paclitaxel, Feasiblity reserach, Implementation research
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True Dose® Capillary Self-Sampling SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Taxane Cohort | Experimental | 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. Receives: Device: True Dose® Capillary Self-Sampling System |
| ALK Inhibitor Cohort | Experimental | 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. Receives: Device: True Dose® Capillary Self-Sampling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
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.
Measured: From first scheduled home sampling until completion of the sampling period, approximately 1 month.
Secondary outcomes (4)
Usability and Acceptability of Capillary Self-Sampling
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.
Measured: Through study completion, approximately 3 months
Need for Assistance With Capillary Self-Sampling
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.
Measured: Through study completion, approximately 3 months
Laboratory Sample Suitability
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.
Measured: Through study completion, approximately 3 months
Barriers and Facilitators to Implementation of Capillary Self-Sampling
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.
Measured: Through study completion, approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are included in one of two parallel cohorts according to their ongoing standard-of-care cancer treatment: taxane therapy (docetaxel or paclitaxel) or ALK inhibitor therapy (alectinib or lorlatinib). Treatment is not assigned by the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Project-COMFORT, Stockholm School of Economics Institute for Research (SIR), ALK Positive Sverige, Sweden, True Dose AB, Vinnova, Karolinska University Hospital
- Responsible party
- Principal investigator, Elham Hedayati, Karolinska Institutet
- Investigators
- Simon Ekman, Professor, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823725
- Sponsor's protocol ID
- Dnr 2026-01638-01
- Acronym
- TD-Lung
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Groenland 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.
PubMed 32686074Maass 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.
PubMed 36129129Komninos 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.
PubMed 41023074Crafoord 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.
PubMed 40678388Mc 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.
PubMed 34944899Kicken 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.
PubMed 40045151Beumer JH. Without therapeutic drug monitoring, there is no personalized cancer care. Clin Pharmacol Ther. 2013 Mar;93(3):228-30. doi: 10.1038/clpt.2012.243. No abstract available.
PubMed 23419487Hertz DL, Joerger M, Bang YJ, Mathijssen RH, Zhou C, Zhang L, Gandara D, Stahl M, Monk BJ, Jaehde U, Beumer JH. Paclitaxel therapeutic drug monitoring - International association of therapeutic drug monitoring and clinical toxicology recommendations. Eur J Cancer. 2024 May;202:114024. doi: 10.1016/j.ejca.2024.114024. Epub 2024 Mar 19.
PubMed 38513383
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentralized Therapeutic Drug Monitoring of Taxanes and ALK Inhibitors in NSCLC: A Real-World Feasibility Study Using the True Dose Capillary Self-Sampling System
- ClinicalTrials.gov ID
- NCT07823725
- Acronym / sponsor ID
- TD-Lung / Dnr 2026-01638-01
- Keywords
- Therapeutic drug monitoring, Patient-centric microsampling, Capillary self-sampling, Precision dosing, Docetaxel, Alectinib, Lorlatinib, ALK inhibitors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Project-COMFORT, Stockholm School of Economics Institute for Research (SIR), ALK Positive Sverige, Sweden, True Dose AB, Vinnova, Karolinska University Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are included in one of two parallel cohorts according to their ongoing standard-of-care cancer treatment: taxane therapy (docetaxel or paclitaxel) or ALK inhibitor therapy (alectinib or lorlatinib). Treatment is not assigned by the study.
| Arm | Type | Receives |
|---|---|---|
| Taxane Cohort | Experimental | Device: True Dose® Capillary Self-Sampling SystemParticipants 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. |
| ALK Inhibitor Cohort | Experimental | Device: True Dose® Capillary Self-Sampling SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True Dose® Capillary Self-Sampling SystemThe 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. | Device | ALK Inhibitor Cohort, Taxane Cohort |
Primary outcome
Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration
Time frame: 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.
4 secondary outcomes
Usability and Acceptability of Capillary Self-Sampling
Time frame: Through study completion, approximately 3 months
Need for Assistance With Capillary Self-Sampling
Time frame: Through study completion, approximately 3 months
Laboratory Sample Suitability
Time frame: Through study completion, approximately 3 months
Barriers and Facilitators to Implementation of Capillary Self-Sampling
Time frame: Through study completion, approximately 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 32686074Groenland 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.
- Background: PubMed 36129129Maass 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.
- Background: PubMed 41023074Komninos 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.
- Background: PubMed 40678388Crafoord 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.
- Background: PubMed 34944899Mc 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.
- Background: PubMed 40045151Kicken 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.
- Background: PubMed 23419487Beumer JH. Without therapeutic drug monitoring, there is no personalized cancer care. Clin Pharmacol Ther. 2013 Mar;93(3):228-30. doi: 10.1038/clpt.2012.243. No abstract available.
- Background: PubMed 38513383Hertz DL, Joerger M, Bang YJ, Mathijssen RH, Zhou C, Zhang L, Gandara D, Stahl M, Monk BJ, Jaehde U, Beumer JH. Paclitaxel therapeutic drug monitoring - International association of therapeutic drug monitoring and clinical toxicology recommendations. Eur J Cancer. 2024 May;202:114024. doi: 10.1016/j.ejca.2024.114024. Epub 2024 Mar 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elin Backman Stålnacke, Speciliased Nurse in Oncology contact
Simon Ekman, Professor, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True Dose® Capillary Self-Sampling System in people with Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elin Backman Stålnacke, Speciliased Nurse in Oncology (+46 8 123 711 85, elin.backman-stalnacke@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Decentralized Capillary Self-Sampling With Reportable Drug Concentration (time frame: From first scheduled home sampling until completion of the sampling period, approximately 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823725, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.