Solid Neoplasms With NTRK FusionsSPAINTRKNCT06837090
Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)
An observational study of Solid Neoplasms With NTRK Fusions, run by Grupo Espanol de Tumores Neuroendocrinos at 14 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Neoplasms With NTRK Fusions
- How many people
- 20 participants
- Where
- 14 sitesSpain
- Study dates
- 11 Feb 2025to 4 Nov 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patients with solid neoplasms with NTRK fusions.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital San Joan de Deu
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Son Espases
Palma, Baleres, 07120
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
Hospital Quirón Salud Torrevieja
Torrevieja, Alicante, 03184
About this study
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.
Read the detailed description
- Study title Retrospective analysis of the experience with Larotrectinib in patients with solid neoplasms with NTRK fusion in Spain (SPAINTRK)
- .RATIONALE AND OBJECTIVES 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 Food and Drug Administration (FDA) and the European Medicines Agency (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 2.1 Main Objective Description of the effectiveness of Larotrectinib treatment in tumors with NTRK fusion in Spanish patients as a clinical series. 2.2. Secondary Objectives
- Describe treatment duration, including dose reductions and interruptions occurred along the treatment with Larotrebtinib, as well as to study the reasons behind those decisions.
- Study the effectiveness of Larotrebtinib and previous lines of therapy. Identified the line of treatment at which molecular testing for NTRK was performed.
- Exploration of clinical and/or histological variables related to the effectiveness and tolerability of Larotrectinib treatment.
- RESEARCH METHODS 3.1. Study design 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. The assignment of a patient to a specific therapeutic strategy has been already 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 will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice. Epidemiological methods will be used to analyze the data collected. 3.2. Setting and study population 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. 3.3. 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. 3.4. 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. 3.5. Study Size The sample size calculation is based on the actual number of patients known to be treated in Spain with Larotrectinib. At the moment 19 patients from 14 different healthcare centers have been localized that were treated in the Spanish territory with Larotrectinib. We expect to include and collect data from all of them. 3.6. Sampling and recruitment method Patients will be consecutively included, in compliance with the previously established inclusion criteria. According to the definition of study population and disease established in this scientific report, patients will be selected from cases diagnosed with solid neoplasms bearing NTRK fusions detected by any of these methods, NGS, FISH and/or IHC, and treated with Larotrectinib. The 19 patients treated with Larotrectinib in the Spanish territory are localized and belong to 14 different sites/healthcare centers. To prevent two or more reporting physicians from logging the same case, a coordinator, who controls the cases included in his or her center, is appointed in health centers with several reporting physicians, and preventive measures are implemented in the tool controlling duplications in variables (such as birth date, gender, center or diagnosis). 3.7. Case Definition A 'case' is defined as any patient, diagnosed, treated, or followed in the different health centers where reporting physicians authorized by the sponsor, who meets the inclusion criteria. A key point is that the patient was diagnosed with solid neoplasms that harbors a NTRK fusion and he/she was receiving treatment with Larotrectinib. Data from patient's treatment should have been recorded and be available at the centers. 3.8. Data Logging Once the patient is compliant with inclusion/exclusion criteria information on the clinical history will be collected to gather the necessary data and to complete the electronic forms of the study designed for this purpose. All data collected during treatment, as well as demographic data, will be provided for the purpose of this study and completed at the electronic Case Report Form (eCRF) to proceed to its analysis.
- ENDPOINTS AND VARIABLES 4.1. Endpoints 4.1.1. Primary Endpoints 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. Results will be presented as individual cases, not compiled as the patients have different pathologies which may differ in prognosis. 4.1.2. Secondary Effectiveness Endpoints
- Objective response rate (ORR): is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as RECIST V1.1. This will be considered as the number of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the period of treatment with Larotrectinib. Tumor measurements that were assessed locally by the clinician according to RECIST, V1.1, should be recorded and indicate the change in size of tumors as compared with baseline, at the first dose of study treatment.
- Progression free survival (PFS): Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.
- Overall survival (OS): defined as the time elapsed from the first dose of study treatment until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patients' status at each visit. Results will be presented as individual cases, not compiled as the patients have different pathologies which may differ in prognosis. 4.1.3. Secondary Safety Endpoints -Safety: All safety information will be collected retrospectively according to data available in the chart review. A descriptive analysis of adverse events collected in medical charts will be done taking into account:
- The frequency of Adverse events (AEs) will be reported per patient by MedDRA System Organ Class (SOC) and Preferred Term (PT);
- The maximum CTCAE grade will be reported per patient;
- The causal relationship with the study drug will be assessed locally by the investigator
- Larotrectinib interruptions / Delays: number of interruptions and delays of treatment reported per patient (frequency) and reason for dose interruption / delay.
- Larotrectinib dose reductions or modifications: Number of reductions or modifications of doses reported per patient (frequency) and reason for dose reduction / modification.
- Larotrectinib treatment duration: Time elapsed between first dose and permanent discontinuation of the study treatment. 4.2. Study Variables Investigators will provide information of each of the following variables: Variables for Demography:
- Age at enrollment.
- Sex (male, female).
- Race (white, black, Asian, other)
- Height (cm).
- Weight (kg).
- Body mass index.
- Body surface area (BSA) - calculated from the reported height and weight using Mostseller's formula: BSA (m2)= (height (cm) x weight (kg) / 3600) 1/2
- Performance status.will be presented using the Eastern Cooperative Oncology - Group (ECOG) scale. Cancer history:
- Primary cancer diagnosis.
- Primary tumor type, histology and location
- Stage of disease at initial diagnosis(I-IV).
- Time since initial diagnosis.
- Extent of disease at enrollment (metastatic, locally advanced, sites of disease, presence of at least one measurable lesion). Stage of the disease at inclusion
- Time since diagnosis of metastatic or locally advanced disease (years). Prior anticancer treatments: -Prior systemic treatments type, start and end dates. -Number of prior systemic regimens or treatment courses. -Best overall response to the most recent prior systemic regimen or treatment course (CR, PR, stable disease, progressive disease, unknown or inevaluable or not applicable). -Prior radiotherapy. -Prior cancer-related surgery. NTRK fusions: -NTRK fusion gene: NTRK1, NTRK2, NTRK3. -NTRK fusion isoform (i.e ETV6-NTRK3). -Method of detection: NGS, FISH or IHC and dates of the determinations.
- Other oncogenic alterations present. Treatment with Larotrectinib: -Dose of Larotrectinib. -Larotrectinib start and end date. Reasons for end of treatment -Data records of dose reductions and/or interruptions and their reason. -Best response and best response date -Progression date. -Frequency of AEs reported per patient by MedDRA System Organ Class (SOC) and Preferred Term (PT); the maximum CTCAE grade will be reported per patient. Causal relationship with the study treatment will be reported for all events. Survival:
- Patient status (alive, death, lost to follow-up)
- Reasons of death (if applicable)
- Subsequent anticancer treatments (type, start and end dates, best response, progression dates)
- Conditions
- Solid Neoplasms With NTRK Fusions
- Keywords
- neoplasm, NTRK, Larotrectinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the study period, an average of 3 year
Secondary outcomes (8)
Objective Response Rate (ORR)
Objective response rate (ORR) is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as RECIST V1.1. This will be considered as the number of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the period of treatment with Larotrectinib. Tumor measurements that were assessed locally by the clinician according to RECIST, V1.1, should be recorded and indicate the change in size of tumors as compared with baseline, at the first dose of study treatment.
Measured: Throughout the study period, an average of 3 year
Progression Free Survival (PFS)
Progression free survival (PFS): Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.
Data is provided for each patient, not compiled.
Measured: Throughout the study period, an average of 3 year and up to 6 years
Overall Survival (OS):
Overall survival (OS): defined as the time elapsed from the first dose of study treatment until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patients' status at each visit.
Results will be presented as individual cases, not compiled as the patients have different pathologies which may differ in prognosis.
Data provided per patient, not compiled. There are 20 rows (i.e. 20 patients analyzed)
Measured: Throughout the study period, an average of 3 year and up to 6 years
Safety_ Frequency of Adverse Events (AEs)
Number of patients who experienced AEs. The AEs are graded according to national cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Throughout the study period, an average of 3 year
Safety _Toxicities
Number of patients who experienced treatment related adverse events. The toxicities are graded according to national cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Measured: Throughout the study period, an average of 3 year
Larotrectinib Interruptions
Number of patients with larotrectinib interruptions
Measured: Throughout the study period, an average of 3 year
Larotrectinib Dose Reductions
Number of patients with larotrectinib reductions
Measured: Throughout the study period, an average of 3 year
Larotrectinib Treatment Duration
Larotrectinib treatment duration. Time elapsed between first dose and permanent discontinuation of the study treatment.
Measured: Throughout the study period, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start11 Feb 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid Neoplasms With NTRK FusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Sponsor type
- University, hospital or other
- Collaborators
- MFAR, Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)
- Responsible party
- Sponsor
- Investigators
- Jorge Hernando Cubero, M.D., Ph.D., Study director, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837090
- Sponsor's protocol ID
- GETNE S2411
- Other IDs
- GETNE S2411/ SPAINTRK
- Acronym
- SPAINTRK
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2025
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (SPAINTRK)
- ClinicalTrials.gov ID
- NCT06837090
- Acronym / sponsor ID
- SPAINTRK / GETNE S2411
- Conditions
- Solid Neoplasms With NTRK Fusions
- Keywords
- neoplasm, NTRK, Larotrectinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
- Collaborators
- MFAR, Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study title Retrospective analysis of the experience with Larotrectinib in patients with solid neoplasms with NTRK fusion in Spain (SPAINTRK)
- .RATIONALE AND OBJECTIVES 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 Food and Drug Administration (FDA) and the European Medicines Agency (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 2.1 Main Objective Description of the effectiveness of Larotrectinib treatment in tumors with NTRK fusion in Spanish patients as a clinical series. 2.2. Secondary Objectives
- Describe treatment duration, including dose reductions and interruptions occurred along the treatment with Larotrebtinib, as well as to study the reasons behind those decisions.
- Study the effectiveness of Larotrebtinib and previous lines of therapy. Identified the line of treatment at which molecular testing for NTRK was performed.
- Exploration of clinical and/or histological variables related to the effectiveness and tolerability of Larotrectinib treatment.
- RESEARCH METHODS 3.1. Study design 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. The assignment of a patient to a specific therapeutic strategy has been already 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 will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice. Epidemiological methods will be used to analyze the data collected. 3.2. Setting and study population 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. 3.3. 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. 3.4. 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. 3.5. Study Size The sample size calculation is based on the actual number of patients known to be treated in Spain with Larotrectinib. At the moment 19 patients from 14 different healthcare centers have been localized that were treated in the Spanish territory with Larotrectinib. We expect to include and collect data from all of them. 3.6. Sampling and recruitment method Patients will be consecutively included, in compliance with the previously established inclusion criteria. According to the definition of study population and disease established in this scientific report, patients will be selected from cases diagnosed with solid neoplasms bearing NTRK fusions detected by any of these methods, NGS, FISH and/or IHC, and treated with Larotrectinib. The 19 patients treated with Larotrectinib in the Spanish territory are localized and belong to 14 different sites/healthcare centers. To prevent two or more reporting physicians from logging the same case, a coordinator, who controls the cases included in his or her center, is appointed in health centers with several reporting physicians, and preventive measures are implemented in the tool controlling duplications in variables (such as birth date, gender, center or diagnosis). 3.7. Case Definition A 'case' is defined as any patient, diagnosed, treated, or followed in the different health centers where reporting physicians authorized by the sponsor, who meets the inclusion criteria. A key point is that the patient was diagnosed with solid neoplasms that harbors a NTRK fusion and he/she was receiving treatment with Larotrectinib. Data from patient's treatment should have been recorded and be available at the centers. 3.8. Data Logging Once the patient is compliant with inclusion/exclusion criteria information on the clinical history will be collected to gather the necessary data and to complete the electronic forms of the study designed for this purpose. All data collected during treatment, as well as demographic data, will be provided for the purpose of this study and completed at the electronic Case Report Form (eCRF) to proceed to its analysis.
- ENDPOINTS AND VARIABLES 4.1. Endpoints 4.1.1. Primary Endpoints 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. Results will be presented as individual cases, not compiled as the patients have different pathologies which may differ in prognosis. 4.1.2. Secondary Effectiveness Endpoints
- Objective response rate (ORR): is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as RECIST V1.1. This will be considered as the number of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the period of treatment with Larotrectinib. Tumor measurements that were assessed locally by the clinician according to RECIST, V1.1, should be recorded and indicate the change in size of tumors as compared with baseline, at the first dose of study treatment.
- Progression free survival (PFS): Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.
- Overall survival (OS): defined as the time elapsed from the first dose of study treatment until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patients' status at each visit. Results will be presented as individual cases, not compiled as the patients have different pathologies which may differ in prognosis. 4.1.3. Secondary Safety Endpoints -Safety: All safety information will be collected retrospectively according to data available in the chart review. A descriptive analysis of adverse events collected in medical charts will be done taking into account:
- The frequency of Adverse events (AEs) will be reported per patient by MedDRA System Organ Class (SOC) and Preferred Term (PT);
- The maximum CTCAE grade will be reported per patient;
- The causal relationship with the study drug will be assessed locally by the investigator
- Larotrectinib interruptions / Delays: number of interruptions and delays of treatment reported per patient (frequency) and reason for dose interruption / delay.
- Larotrectinib dose reductions or modifications: Number of reductions or modifications of doses reported per patient (frequency) and reason for dose reduction / modification.
- Larotrectinib treatment duration: Time elapsed between first dose and permanent discontinuation of the study treatment. 4.2. Study Variables Investigators will provide information of each of the following variables: Variables for Demography:
- Age at enrollment.
- Sex (male, female).
- Race (white, black, Asian, other)
- Height (cm).
- Weight (kg).
- Body mass index.
- Body surface area (BSA) - calculated from the reported height and weight using Mostseller's formula: BSA (m2)= (height (cm) x weight (kg) / 3600) 1/2
- Performance status.will be presented using the Eastern Cooperative Oncology - Group (ECOG) scale. Cancer history:
- Primary cancer diagnosis.
- Primary tumor type, histology and location
- Stage of disease at initial diagnosis(I-IV).
- Time since initial diagnosis.
- Extent of disease at enrollment (metastatic, locally advanced, sites of disease, presence of at least one measurable lesion). Stage of the disease at inclusion
- Time since diagnosis of metastatic or locally advanced disease (years). Prior anticancer treatments: -Prior systemic treatments type, start and end dates. -Number of prior systemic regimens or treatment courses. -Best overall response to the most recent prior systemic regimen or treatment course (CR, PR, stable disease, progressive disease, unknown or inevaluable or not applicable). -Prior radiotherapy. -Prior cancer-related surgery. NTRK fusions: -NTRK fusion gene: NTRK1, NTRK2, NTRK3. -NTRK fusion isoform (i.e ETV6-NTRK3). -Method of detection: NGS, FISH or IHC and dates of the determinations.
- Other oncogenic alterations present. Treatment with Larotrectinib: -Dose of Larotrectinib. -Larotrectinib start and end date. Reasons for end of treatment -Data records of dose reductions and/or interruptions and their reason. -Best response and best response date -Progression date. -Frequency of AEs reported per patient by MedDRA System Organ Class (SOC) and Preferred Term (PT); the maximum CTCAE grade will be reported per patient. Causal relationship with the study treatment will be reported for all events. Survival:
- Patient status (alive, death, lost to follow-up)
- Reasons of death (if applicable)
- Subsequent anticancer treatments (type, start and end dates, best response, progression dates)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients with solid neoplasms with NTRK fusions.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of Response (DoR)
Time frame: Throughout the study period, an average of 3 year
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.
8 secondary outcomes
Objective Response Rate (ORR)
Time frame: Throughout the study period, an average of 3 year
Progression Free Survival (PFS)
Time frame: Throughout the study period, an average of 3 year and up to 6 years
Overall Survival (OS):
Time frame: Throughout the study period, an average of 3 year and up to 6 years
Safety_ Frequency of Adverse Events (AEs)
Time frame: Throughout the study period, an average of 3 year
Safety _Toxicities
Time frame: Throughout the study period, an average of 3 year
Larotrectinib Interruptions
Time frame: Throughout the study period, an average of 3 year
Larotrectinib Dose Reductions
Time frame: Throughout the study period, an average of 3 year
Larotrectinib Treatment Duration
Time frame: Throughout the study period, an average of 3 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Hernando Cubero, M.D., Ph.D. study director
Hospital Vall d'Hebron
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Neoplasms With NTRK Fusions, run by Grupo Espanol de Tumores Neuroendocrinos at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Response (DoR) (time frame: Throughout the study period, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.