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

Comparative Effectiveness Study of Real-world Control of TRK Fusion Positive Cancer With Patients From Larotrectinib (Vitrakvi) Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors Harboring NTRK Fusion
• Intervention / Treatment: Drug: Larotrectinib(Vitrakvi, BAY2757556); Drug: Data on other treatments

• Study Type: Observational
• Enrollment (Actual): 368

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Data is collected globally.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Larotrectinib clinical trial cohort	Drug: Larotrectinib(Vitrakvi, BAY2757556); Clinical trials
RW external comparator cohort	Drug: Data on other treatments; Real word data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Retrospective analysis from January 2013 to August 2022

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Treatment patterns	Retrospective analysis from January 2013 to August 2022

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No