N/A
Completed N=20
Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)
Solid Neoplasms With NTRK Fusions
Source: ClinicalTrials.gov NCT06837090 ↗
Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Feb 2026
Primary outcomePrimary: Duration of Response (DoR) — 24.5 months
Summary
SPAINTRK aims to be the first trial in Spain to systematically collect data on outcomes of Spanish patients with solid neoplasms treated with Larotrectinib through the compassionate drug use program, during the time elapsed between the indication approval and the drug commercialization. This will contribute to selection of the best treatment for cancer patients with NTRK fusions, such as Trk inhibitors like Larotrectinib. Since the FDA and the EMA approved the use of Trk inhibitors, like Larotrectinib, there is a new and effective option of treatment for patients with NTRK fusions in solid neoplasms. This observational retrospective study will allow to analyze data of patients treated with Larotrectinib across the country and increase the knowledge on response to rare and different cancers Main objective is describe the effectiveness of Larotrectinib treatment in tumors with NTRK fusion in Spanish patients as a clinical series.
This is an observational retrospective study including cancer patients with solid neoplasms with NTRK fusions.
The study will use secondary data retrieved from medical records from each patient. The medical records include all the clinical variables defined in order to perform the analysis and it is not necessary to access additional sources.In total, 19 patients diagnosed with solid neoplasms that have been confirmed to bear NTRK fusions in their tumors will be included in the study. It is known that these patients have received the treatment with Larotrectinib in 14 centers in Spain, prior to treatment reimbursement in Spain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Response (DoR) |
24.5 | — |
| SECONDARY Objective Response Rate (ORR) |
4; 8; 7; 1 | — |
| SECONDARY Progression Free Survival (PFS) |
15.0; 4.7; 2.5; 23.2; 35.0; 27.7 | — |
| SECONDARY Overall Survival (OS): |
27.8; 8.9; 6.7; 23.2; 35.0; 27.7 | — |
| SECONDARY Safety_ Frequency of Adverse Events (AEs) |
11; 9; 6; 14 | — |
| SECONDARY Safety _Toxicities |
10; 10; 5; 15 | — |
| SECONDARY Larotrectinib Interruptions |
5; 15 | — |
| SECONDARY Larotrectinib Dose Reductions |
3; 17 | — |
| SECONDARY Larotrectinib Treatment Duration |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Infant and adult patients (all ages).
- Patients with confirmed diagnosis of solid neoplasms.
- Patients must have detected NTRK fusions by the following diagnostic methods NGS, fluorescence in situ hybridization (FISH) and/or Immunohistochemistry (IHC).
- Patients must be treated with Larotrectinib under the compassionate use program (before the commercialization) in order to be included in the study.
- Data should be available in order to evaluate effectiveness and consequent follow up.
Exclusion Criteria
- Patients with solid neoplasms treated with Larotrectinib in clinical trials or other settings different from clinical practice.
- Patients that initiated treatment with Larotrectinib after the obtention of prize-reimbursement and commercialization
Data sourced from ClinicalTrials.gov (NCT06837090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.