A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice

Completed

• Conditions: Solid Tumors Harboring NTRK Fusion
• Interventions: Drug: Larotrectinib(Vitrakvi, BAY2757556); Drug: Data on other treatments

• Registration Number: NCT05192642
• Lead Sponsor: Bayer

Brief Summary

This is an observational study in which patient data from the past of adult people with solid tumors harboring NTRK gene fusion are studied. This study will focus on 5 tumor types which have been at the late stage or have spread to other parts of the body. These 5 tumor types are:

* Non-small-cell-lung cancer

* Colorectal cancer (located in the intestine)

* Thyroid cancer

* Sarcomas (located in the connective tissue like bones or body fat)

* Salivary gland carcinoma

In some people with cancer, the cancer cells have specific changes in their building plans (genes) called NTRK gene fusion. NTRK stands for neurotrophic tyrosine receptor kinase, the specific gene that is changed. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive. While NTRK is the gene, TRK (tropomyosin receptor kinase) is the name of the protein. The specific cancer is therefore also called TRK fusion-positive cancer.

The study drug, larotrectinib works by blocking the altered TRK fusion protein. Larotrectinib is already available in the US, Europe, and in other countries and is approved for doctors to prescribe to patients with TRK fusion cancer.

The main purpose of this study is to learn more about how well larotrectinib works in adults with TRK fusion-positive cancer compared to other treatments. Researchers will compare how long participants who received larotrectninib lived to how long participants who received other treatments lived. To do this, larotrectinib data from past clinical studies will be compared with data on other treatments gathered from different health data sources. The data will cover the time between January 2013 and end of August 2022.

Besides this data collection, no further tests or examinations are planned and no visits are required in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-14
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 368

Inclusion Criteria

• Diagnosis of advanced stage of disease or metastatic disease.

Exclusion Criteria

• Patients involved in TRK inhibitor clinical trials will be excluded from RW control cohort.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Larotrectinib clinical trial cohort	Larotrectinib(Vitrakvi, BAY2757556)	-
RW external comparator cohort	Data on other treatments	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Retrospective analysis from January 2013 to August 2022

Secondary Outcome Measures

Name	Time	Method
Overall Treatment patterns	Retrospective analysis from January 2013 to August 2022

Trial Locations

Locations (1)

Bayer; 🇺🇸 Whippany, New Jersey, United States