NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

Study Overview
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Brief Summary
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Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or fuses with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing. In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The study will include patients of all ages with TRK fusion cancer. In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from: the patients' medical records interviews with the patients or their parents or guardians the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.

Official Title
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Special Drug Use Investigation for Larotrectinib

Conditions
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Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Intervention / Treatment
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* Drug: Larotrectinib (Vitrakvi, BAY2757556)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice. Exclusion Criteria: Participation in an investigational program with interventions outside of routine clinical practice
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastrointestinal (GI)<br>Participants with GI cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Head and neck (H&N)<br>Participants with H&N cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Lung<br>Participants with lung cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Soft tissue sarcoma (STS)<br>Participants with STS cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Primary central nervous system (CNS)<br>Participants with CNS cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Melanoma<br>Participants with Melanoma cancer. | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Pediatrics<br> | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|
| Others<br> | Drug: Larotrectinib (Vitrakvi, BAY2757556)<br>* Follow clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of treatment emergent adverse events (TEAEs) |  | Approximate 8 years | 
| Frequency of TEAEs |  | Approximate 8 years | 
| Seriousness of TEAEs |  | Approximate 8 years | 
| Outcome of TEAEs |  | Approximate 8 years | 
| Causality assessment of TEAEs |  | Approximate 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment |  | Approximate 8 years | 
| Disease control rate (DCR) |  | Approximate 8 years | 
| Duration of response (DOR) |  | Approximate 8 years | 
| Time to response (TTR) |  | Approximate 8 years | 
| Progression-free survival (PFS) |  | Approximate 8 years | 
| Overall survival (OS) |  | Approximate 8 years | 
| Total dose |  | Approximate 8 years | 
| Starting and ending dose |  | Approximate 8 years | 
| Dose modification during treatment |  | Approximate 8 years | 
| Duration of treatment (DOT) |  | Approximate 8 years | 
| Baseline characteristics | Including but not limited to: age, NTRK gene, NTRK gene partner, prior therapy (type, number of lines of therapy), other. | Approximate 8 years | 
| Neurological examination (normal/abnormal) |  | Approximate 8 years | 
| Change in height from baseline by visit |  | Approximate 8 years | 
| Change in weight from baseline by visit |  | Approximate 8 years | 
| Developmental milestones abnormalities (normal/abnormal) |  | Approximate 8 years |