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Observational study on the safety and effectiveness of VITRAKVI for TRK fusion cancer

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

Observational Bayer · NCT04142437

This study is looking at how well the drug VITRAKVI works and how safe it is for both adults and kids with certain types of cancer that have an NTRK gene fusion.

Quick facts

Study typeObservational
Enrollment150 (estimated)
SexAll
SponsorBayer Industry-sponsored
Drugs / interventionslarotrectinib
Locations76 sites (Mesa, Arizona and 75 other locations)
Trial IDNCT04142437 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather information on the effectiveness and tolerability of the drug VITRAKVI (larotrectinib) in patients with locally advanced or metastatic solid tumors that harbor an NTRK gene fusion. The study will enroll both adult and pediatric patients who have been prescribed VITRAKVI by their treating physicians. Researchers will monitor the outcomes and side effects of the drug during routine clinical use, providing valuable insights into its real-world effectiveness. The study will utilize various genomic testing methods to confirm the presence of NTRK gene fusions in participants.

Who should consider this trial

Good fit: Ideal candidates include adults and pediatric patients with locally advanced or metastatic solid tumors that have been confirmed to harbor an NTRK gene fusion.

Not a fit: Patients without an NTRK gene fusion or those who are not eligible for treatment with VITRAKVI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical data on the real-world effectiveness of VITRAKVI, potentially improving treatment options for patients with TRK fusion cancer.

How similar studies have performed: Other studies have shown promising results with VITRAKVI in treating TRK fusion cancers, indicating a potential for success in this observational approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult and pediatric (from birth to 18-year-old) patients
* Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
* Life expectancy of at least 3 months based on clinical judgement
* Decision to treat with larotrectinib made by the treating physician prior to study enrollment
* Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
* Signed informed consent form
* For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

* Any contraindications as listed in the local approved product information
* Pregnancy
* Participation in an investigational program with interventions outside of routine clinical practice
* Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
* Patients with NTRK gene amplification or NTRK point mutation

Where this trial is running

Mesa, Arizona and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.