Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionON-TRKNCT04142437
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body
An observational study of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, run by Bayer at 47 sites in 15 countries.
Trial summary
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
- What is being tested?
- larotrectinib(Vitrakvi, BAY2757556)
- How many people
- 54 participants
- Where
- 47 sitesin 15 countries
- Study dates
- 3 Apr 2020to 1 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
47 sites in 15 countries.
47 sites in 15 countries
United States33 sites
Johns Hopkins / Sidney Kimmel Cancer Center
Baltimore, Maryland, 21205
Tufts / Neely Cancer Center
Boston, Massachusetts, 02111
Great Lakes Cancer Center
Buffalo, New York, 14210
Medical Univ. of South Carolina
Charleston, South Carolina, 29425
UT Southwestern Medical Center / Children's Health
Dallas, Texas, 75390
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Fort Wayne Medical Oncology Hematology
Fort Wayne, Indiana, 46804
Frederick Health-James M Stockman Cancer Institute
Frederick, Maryland, 21702
East Carolina University / Vidant Health
Greenville, North Carolina, 27834
MD Anderson Cancer Center
Houston, Texas, 77030
Gundersen Health System
La Crosse, Wisconsin, 54601
Sparrow Cancer Center
Lansing, Michigan, 48912
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89169
California Research Inst.
Los Angeles, California, 90027
UCLA - Mattel Children's Hospital
Los Angeles, California, 90095
SSM Health Cancer Center - Dean Medical Group
Madison, Wisconsin, 53717
University of Miami
Miami, Florida, 33146
Nicklaus Children's Hospital
Miami, Florida, 33155
West Virginia University
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06520
Memorial Sloan Kettering Children's Cancer Center
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 82663
Stanford Univ Med Ctr. / Lucile Packard Children's Hosp
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Univ. of Utah / Huntsman Cancer Center
Salt Lake City, Utah, 84112
Providence Health System - Southern California
Santa Monica, California, 90404
Seattle Children's
Seattle, Washington, 98105
Maine Health
South Portland, Maine, 04106
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Cancer Center of Kansas
Wichita, Kansas, 67214
Mercy Health Youngstown
Youngstown, Ohio, 44501
About this study
Official title: PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
- Being tested
- larotrectinib(Vitrakvi, BAY2757556)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larotrectinib(Vitrakvi, BAY2757556)Drug
In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
| Study group | Role | What they receive |
|---|---|---|
| GI | adult patients with gastrointestinal (GI) cancer Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| H&N | adult patients with head and neck (H\&N) cancer Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| STS | adult patients with soft tissue sarcoma (STS) Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| CNS | adult patients with primary central nervous system (CNS) cancer Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| Lung | adult patients with lung cancer Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| Melanoma | adult patients with melanoma Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| Pediatric | all pediatric patients regardless of tumor type will be enrolled under this cohort Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) | |
| other | patients with other tumor types Receives: Drug: larotrectinib(Vitrakvi, BAY2757556) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 30 days after last dose
Severity of TEAEs
Measured: Up to 30 days after last dose
Seriousness of TEAEs
Measured: Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Measured: Up to 30 days after last dose
Causality of TEAEs
Measured: Up to 30 days after last dose
Action taken related to larotrectinib treatment
Measured: Up to 30 days after last dose
Secondary outcomes (19)
Objective response rate (ORR)
Measured: Up to 8 years
Disease control rate (DCR)
Measured: Up to 8 years
Duration of response (DOR)
Measured: Up to 8 years
Time to response (TTR)
Measured: Up to 8 years
Progression-free survival (PFS)
Measured: Up to 8 years
Overall survival (OS)
Measured: Up to 8 years
Total dose
Measured: Up to 8 years
Starting and ending dose
Measured: Up to 8 years
Dose modification during treatment
Measured: Up to 8 years
Duration of treatment (DOT)
Measured: Up to 8 years
ORR by patient subgroup(s)
Measured: Up to 8 years
DCR by patient subgroup(s)
Measured: Up to 8 years
DOR by patient subgroup(s)
Measured: Up to 8 years
TTR by patient subgroup(s)
Measured: Up to 8 years
PFS by patient subgroup(s)
Measured: Up to 8 years
OS by patient subgroup(s)
Measured: Up to 8 years
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
for all patients
Measured: Up to 8 years
Number of patients with abnormal developmental milestones
Pediatric cohort only
Measured: Up to 8 years
Number of patients with abnormal Tanner stage
Pediatric cohort only
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start3 Apr 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142437
- Sponsor's protocol ID
- 20324
- Acronym
- ON-TRK
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.
PubMed 35672677
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
- ClinicalTrials.gov ID
- NCT04142437
- Acronym / sponsor ID
- ON-TRK / 20324
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| GI | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with gastrointestinal (GI) cancer |
| H&N | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with head and neck (H\&N) cancer |
| STS | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with soft tissue sarcoma (STS) |
| CNS | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with primary central nervous system (CNS) cancer |
| Lung | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with lung cancer |
| Melanoma | – | Drug: larotrectinib(Vitrakvi, BAY2757556)adult patients with melanoma |
| Pediatric | – | Drug: larotrectinib(Vitrakvi, BAY2757556)all pediatric patients regardless of tumor type will be enrolled under this cohort |
| other | – | Drug: larotrectinib(Vitrakvi, BAY2757556)patients with other tumor types |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric (from birth to 18-year-old) patients with a locally advanced or metastatic solid tumor harboring an NTRK gene fusion (detected by NGS (Next-Generation Sequencing), FISH (Fluorescent In Situ Hybridization), rt-PCR (Reverse Transcription Polymerase Chain Reaction) or other genomic testing able to detect NTRK gene fusion) assessed locally for whom a decision to treat with larotrectinib has been made before enrollment
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| larotrectinib(Vitrakvi, BAY2757556)In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol | Drug | CNS, GI, H&N, Lung, Melanoma, Pediatric, STS, other |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 30 days after last dose
Severity of TEAEs
Time frame: Up to 30 days after last dose
Seriousness of TEAEs
Time frame: Up to 30 days after last dose
Reasonable causal relationship between larotrectinib and an AE
Time frame: Up to 30 days after last dose
Causality of TEAEs
Time frame: Up to 30 days after last dose
Action taken related to larotrectinib treatment
Time frame: Up to 30 days after last dose
19 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 8 years
Disease control rate (DCR)
Time frame: Up to 8 years
Duration of response (DOR)
Time frame: Up to 8 years
Time to response (TTR)
Time frame: Up to 8 years
Progression-free survival (PFS)
Time frame: Up to 8 years
Overall survival (OS)
Time frame: Up to 8 years
Total dose
Time frame: Up to 8 years
Starting and ending dose
Time frame: Up to 8 years
Dose modification during treatment
Time frame: Up to 8 years
Duration of treatment (DOT)
Time frame: Up to 8 years
ORR by patient subgroup(s)
Time frame: Up to 8 years
DCR by patient subgroup(s)
Time frame: Up to 8 years
DOR by patient subgroup(s)
Time frame: Up to 8 years
TTR by patient subgroup(s)
Time frame: Up to 8 years
PFS by patient subgroup(s)
Time frame: Up to 8 years
OS by patient subgroup(s)
Time frame: Up to 8 years
Number of patients with change in height and weight from baseline by visit, neurological abnormalities (normal/abnormal)
Time frame: Up to 8 years
Number of patients with abnormal developmental milestones
Time frame: Up to 8 years
Number of patients with abnormal Tanner stage
Time frame: Up to 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 35672677Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.
- Individual participant dataSharing planned: No. 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. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion, run by Bayer at 47 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Argentina, Austria, Belgium, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 30 days after last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.