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

NCT05192642 | Completed

• 1 other identifier: 21993
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors Harboring NTRK Fusion

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Retrospective analysis from January 2013 to August 2022

Secondary Outcomes (1)

• Overall Treatment patterns

  Retrospective analysis from January 2013 to August 2022

Study Arms (2)

Larotrectinib clinical trial cohort

Drug: Larotrectinib(Vitrakvi, BAY2757556)

RW external comparator cohort

Drug: Data on other treatments

Interventions

Larotrectinib(Vitrakvi, BAY2757556) DRUG

Clinical trials

Larotrectinib clinical trial cohort

Data on other treatments DRUG

Real word data

RW external comparator cohort

Eligibility Criteria

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

Study Population

Data is collected globally.

You may qualify if:

• Diagnosis of advanced stage of disease or metastatic disease.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

MeSH Terms

Interventions

larotrectinib

Study Design

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

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: January 14, 2022
• Study Start: December 3, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)