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

Study acronym: TD-Lung
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2027 → Oct 1, 2028
Enrollment reduced 50% 80 → 40 participants
See other at-risk trials from Karolinska Institutet

Record History

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  1. Primary completion pushed from Oct 1, 2027 to Oct 1, 2028
    • Enrollment reduced: 80 → 40 participants
    • Study sites: 1 to 2
    • Collaborators: 5 to 6
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07823725
Lead Sponsor Karolinska Institutet
Collaborators: Project-COMFORT, Stockholm School of Economics Institute for Research (SIR), ALK Positive Sverige, Sweden, True Dose AB, Vinnova, Karolinska University Hospital
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov