Clinical trial NCT05192642: 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
Official title: Comparative Effectiveness Study of Real-world Control of TRK Fusion Positive Cancer With Patients From Larotrectinib (Vitrakvi) Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumors Harboring NTRK Fusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data is collected globally.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Retrospective analysis from January 2013 to August 2022
Secondary outcomes:
measure: Overall Treatment patterns
timeFrame: Retrospective analysis from January 2013 to August 2022
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: