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

NCT06837090 | Completed Results DMC

• 2 other identifiers: GETNE S2411GETNE S2411/ SPAINTRK
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Solid Neoplasms With NTRK Fusions

Keywords

neoplasm; NTRK; Larotrectinib

Outcome Measures

Primary Outcomes (1)

• Duration of Response (DoR)

  Duration of response (DoR): is defined as the time from first confirmed response (complete (CR) or partial (PR) response), according to Objective response rate (ORR) defined below, to the date of the documented progression of the disease (PD) as determined using RECIST V1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.

  Throughout the study period, an average of 3 year

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Throughout the study period, an average of 3 year

• Progression Free Survival (PFS)

  Throughout the study period, an average of 3 year and up to 6 years

• Overall Survival (OS):

  Throughout the study period, an average of 3 year and up to 6 years

• Safety_ Frequency of Adverse Events (AEs)

  Throughout the study period, an average of 3 year

• Safety _Toxicities

  Throughout the study period, an average of 3 year

Study Arms (1)

Cancer patients with solid neoplasms with NTRK fusions.

Cancer patients with solid neoplasms with NTRK fusions. The study will use secondary data retrieved from each patient's medical records. The clinical history includes all the clinical variables defined to perform the analysis and it is not necessary to access additional sources. The assignment of a patient to a specific therapeutic strategy has already been decided in advance by the usual clinical practice of medicine; the decision to prescribe a specific treatment was clearly dissociated from the decision to include a patient in the study. No intervention, neither diagnostic nor follow-up, will be applied to patients other than usual clinical practice. Epidemiological methods will be used to analyze the data collected.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients with solid neoplasms with NTRK fusions.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE): collaborator
• Grupo Espanol de Tumores Neuroendocrinos: lead
• MFAR: collaborator

Study Sites (14)

Hospital Quirón Salud Torrevieja

Torrevieja, Alicante, 03184, Spain

Location

Hospital Universitario Son Espases

Palma, Baleres, 07120, Spain

Location

Hospital San Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Clínico Santiago de Compostela

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Secretary
• Organization: Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)

getne@getne.org

0034934344412

Study Officials

• Jorge Hernando Cubero, M.D., Ph.D.

  Hospital Vall d'Hebron

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 20, 2025
• Study Start: February 11, 2025
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)