Analyzing the use of Larotrectinib for solid tumors with NTRK fusions in Spain

Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)

Observational Grupo Espanol de Tumores Neuroendocrinos · NCT06837090

This study looks at how well Larotrectinib works for Spanish patients with solid tumors that have NTRK fusions to help find better treatment options for these rare cancers.

Quick facts

Study typeObservational
Enrollment19 (estimated)
SexAll
SponsorGrupo Espanol de Tumores Neuroendocrinos Academic / other
Drugs / interventionsLarotrectinib, Larotrebtinib
Locations14 sites (Torrevieja, Alicante and 13 other locations)
Trial IDNCT06837090 on ClinicalTrials.gov

What this trial studies

SPAINTRK is an observational retrospective analysis that collects data on Spanish patients with solid neoplasms treated with Larotrectinib through a compassionate use program. The study aims to evaluate the effectiveness of Larotrectinib in patients with confirmed NTRK fusions, contributing to the selection of optimal treatments for these cancers. By analyzing patient outcomes, the study seeks to enhance understanding of responses to this novel therapy in a real-world setting. The data collected will help inform future treatment strategies for rare cancers associated with NTRK fusions.

Who should consider this trial

Good fit: Ideal candidates include infants and adults with confirmed solid neoplasms and detected NTRK fusions who have been treated with Larotrectinib under compassionate use.

Not a fit: Patients who have received Larotrectinib in clinical trials or after its commercialization will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Larotrectinib, potentially improving treatment options for patients with NTRK fusion-positive solid tumors.

How similar studies have performed: Other studies have shown promising results with Trk inhibitors like Larotrectinib, indicating a potential for success in this observational analysis.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Infant and adult patients (all ages).
2. Patients with confirmed diagnosis of solid neoplasms.
3. Patients must have detected NTRK fusions by the following diagnostic methods NGS, fluorescence in situ hybridization (FISH) and/or Immunohistochemistry (IHC).
4. Patients must be treated with Larotrectinib under the compassionate use program (before the commercialization) in order to be included in the study.
5. Data should be available in order to evaluate effectiveness and consequent follow up.

Exclusion Criteria:

1. Patients with solid neoplasms treated with Larotrectinib in clinical trials or other settings different from clinical practice.
2. Patients that initiated treatment with Larotrectinib after the obtention of prize-reimbursement and commercialization

Where this trial is running

Torrevieja, Alicante and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Solid Neoplasms With NTRK FusionsneoplasmNTRKLarotrectinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.