Letzte Aktualisierung: 24.09.2025
Hirntumor [C71, D33]
ON-TRK - PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Studieninformationen
Ziele
Primäres Prüfziel
The primary objective of this international, non-interventional study is to describe the safety of larotrectinib in patients with locally advanced or metastatic TRK fusion cancer, including incidences of all treatment-emergent adverse events (TEAEs) in real-world practice conditions.
Sekundäre Prüfziele für die Behandlungsarme:
• To describe the effectiveness of larotrectinib, including overall response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS) by local investigator assessments.
• To describe the patterns of larotrectinib treatment, including actual doses, duration of treatment (DOT), and other dosing parameters
• To describe the effectiveness of larotrectinib in subgroups of patients, including but not limited to: by age, NTRK gene, NTRK gene partner, testing methodology, country/region, prior therapy (type and/or number of lines of therapy), and/or by other patient (baseline) characteristics. Additional subgroups may be explored as needed
• To describe long-term effects of larotrectinib on growth (height and weight), neurological outcomes, developmental milestones, and sexual development (Tanner scale) in the pediatric cohort.
• To describe HRQoL of larotrectinib treated patients by PROs in Austria, Canada and Germany
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion.
Mutation
Patienten
Alter
Einschlusskriterien
• Adult and pediatric (from birth to 18 year old) patients
• Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
• Life expectancy of at least 3 months based on clinical judgement
• Decision to treat with larotrectinib made by the treating physician prior to study enrollment
• Signed informed consent form
• For patients under legal age, signed assent by the patient (where applicable) and
parental/legal guardian signed informed consent is required
Ausschlusskriterien
• Any contraindications as listed in the local approved product information
• Pregnancy
• Participation in an investigational program with interventions outside of routine clinical practice
• Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
• Patients with NTRK gene amplification or NTRK point mutation
Therapie
Intervention
Patients with locally advanced or metastatic TRK fusion cancer for whom a decision to treat with larotrectinib has been made before enrollment will be eligible for the study.
Detection of NTRK gene fusion will be by next-generation sequencing (NGS), fluorescent in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information. Examinations and the laboratory monitoring schedule will follow
local label recommendations in line with local standard of care.
Substanz
| Prüfplancode | ON-TRK |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT04142437 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
—
Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




