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Rare Cancers

NTRK Fusion Cancer (NTRK) Clinical Trials and Treatments

Also called NTRK, TRK fusion, NTRK fusion-positive solid tumor, neurotrophic tyrosine receptor kinase fusion, NTRK1, NTRK2, NTRK3, ETV6-NTRK3, infantile fibrosarcoma, secretory carcinoma, larotrectinib cancer, entrectinib cancer

NTRK fusion cancers represent a paradigm shift in oncology toward tissue-agnostic treatment. The NTRK1, NTRK2, and NTRK3 genes encode tropomyosin receptor kinases (TRK A, B, and C), which are normally involved in nervous system development.

FDA-approved medicines

3

Augtyro, Rozlytrek, Vitrakvi

Active trials

11

10 recruiting now

Next FDA decision

None set

FDA calendar

Medicines are those whose current FDA label names NTRK Fusion Cancer, checked October 14, 2026. Corticosteroids and immune globulins count once each. Download the data

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About NTRK Fusion Cancer

NTRK fusion cancers represent a paradigm shift in oncology toward tissue-agnostic treatment. The NTRK1, NTRK2, and NTRK3 genes encode tropomyosin receptor kinases (TRK A, B, and C), which are normally involved in nervous system development. When one of these genes fuses with another gene through a chromosomal rearrangement, the resulting fusion protein is constitutively active, driving uncontrolled cell growth regardless of the tissue of origin.

The breakthrough in NTRK fusion cancer treatment came with the FDA approvals of larotrectinib (Vitrakvi, Bayer) in November 2018 and entrectinib (Rozlytrek, Roche/Genentech) in August 2019, the first targeted kinase inhibitors approved for a molecular marker rather than a tumor location (pembrolizumab had been approved tissue-agnostically for MSI-high tumors in 2017, so the FDA counts larotrectinib as the second tissue-agnostic approval). Larotrectinib, originally developed by Loxo Oncology (acquired by Eli Lilly in February 2019), is a highly selective TRK inhibitor. The first published analysis of 55 patients reported a 75% response rate across 17 tumor types; the current label, based on 339 patients, reports a 60% response rate with 24% complete responses and a median response duration of 43.3 months, with rates ranging from 94% in infantile fibrosarcoma to 27% in primary brain tumors. Larotrectinib received full FDA approval on April 9, 2025, converting from its 2018 accelerated approval. Bayer holds exclusive global commercial rights to Vitrakvi, which is the only one of the 3 drugs with an oral solution and no lower age limit. Entrectinib (Rozlytrek) is approved under accelerated approval for NTRK fusion solid tumors in patients older than 1 month, as well as for ROS1-positive lung cancer; it crosses into the brain and reported a 59% response rate in adults and 70% in children. On June 13, 2024, repotrectinib (Augtyro, Bristol Myers Squibb) received accelerated approval for NTRK fusion solid tumors in patients 12 and older, the first next-generation TRK inhibitor approved in the United States and the only approved option for tumors that have become resistant to larotrectinib or entrectinib, with a 50% response rate in previously treated patients. Two further next-generation TRK inhibitors, zurletrectinib (December 2025) and eratrectinib (June 2026), have been approved in China but not in the United States. Comprehensive genomic profiling (CGP) through next-generation sequencing is essential for identifying patients who may benefit from these targeted therapies, and immunohistochemistry for the TRK protein is used as a screening test in some tumor types.

Common Symptoms of NTRK Fusion Cancer

Recognizing the signs of NTRK Fusion Cancer early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Symptoms vary widely depending on the tumor type and location
  • A growing lump or mass that may or may not be painful
  • Fatigue and unexplained weight loss
  • Pain in the affected area
  • Organ-specific symptoms depending on tumor location
  • Some NTRK fusion tumors are found incidentally on imaging

Who NTRK Fusion Cancer Affects

NTRK fusions can occur at any age, from infants to older adults. They have been identified across more than 2 dozen tumor types. Some cancers like infantile fibrosarcoma and secretory breast carcinoma have very high rates of NTRK fusions, while common cancers like lung and colon cancer have them rarely. No clear ethnic or gender predisposition for the fusion itself.

Find Your Next Step

Find trials I might fit Answer a few questions and see which open NTRK Fusion Cancer trials fit your age, location and treatment history.Compare treatments Every FDA-approved NTRK Fusion Cancer treatment side by side: dosing, results and warnings.

FDA-Approved Treatments for NTRK Fusion Cancer

There are currently 3 FDA-approved medications for NTRK Fusion Cancer. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials. Compare all 3 side by side, with dosing, trial results and warnings from the labels.

repotrectinib
Bristol Myers Squibb
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entrectinib
Genentech (Roche)
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larotrectinib
Bayer
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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NTRK Fusion Cancer Medicines in Clinical Trials

Investigational medicines Trial Friend tracks for NTRK Fusion Cancer, with trial results, safety findings and where each one stands.

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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Genetic Testing

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted NTRK Fusion Cancer Resources

Reputable organizations and medical references for learning more about NTRK Fusion Cancer, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for NTRK Fusion Cancer

Use this NTRK Fusion Cancer clinical trial finder to see the 10 studies recruiting patients and 1 opening soon in the United States and worldwide, with eligibility criteria in plain English. Of these, 7 test a treatment and 4 are observational studies or registries; each card says which. These studies play a critical role in advancing care for rare cancers conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

New to trials? What Placebos and Randomization Actually Mean for You (In Plain English) · 4 min readWorried about cost? The Hidden Costs of Joining a Clinical Trial (And How to Get Help Paying for Them) · 4 min read
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Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

11 active trials worldwide
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RECRUITINGTreatment trialPhase 2Recently updatedNCT01639508

Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

Intervention: Cabozantinib

Sponsor: Memorial Sloan Kettering Cancer Center · Exelixis

The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity.

Ages 18 Years+7 locations
Started Jul 2012Updated 2 days agoEst. Jul 2027 (~9 months)
RECRUITINGObservational study, no treatment givenRecently updatedNCT04142437

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

Intervention: larotrectinib(Vitrakvi, BAY2757556)

Sponsor: Bayer

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 st...

Ages not specified76 locations
Started Apr 2020Updated 1 week agoEst. Nov 2029 (~3y 1m)
NOT YET RECRUITINGObservational study, no treatment givenRecently updatedNCT07599007

Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion

Intervention: Repotrectinib

Sponsor: Bristol-Myers Squibb

This observational study evaluates the real-world safety and effectiveness of repotrectinib in Korean participants with locally advanced or metastatic ROS1-positive non-small cell lung cancer or solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. Par...

Ages 12 Years+1 location
Expected to start Oct 2026Updated 2 weeks agoEst. Dec 2027 (~1y 2m)
RECRUITINGObservational study, no treatment givenRecently updatedNCT07755826

Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan

Intervention: Repotrectinib

Sponsor: Bristol-Myers Squibb

This study will collect safety information during routine medical care for children and adolescents in Japan who have been diagnosed with NTRK fusion-positive advanced or recurrent solid tumors who start treatment with repotrectinib. The study will describe how often side effects...

Ages 4 Years to 17 Years2 locations
Started Nov 2025Updated 2 months agoEst. Apr 2034 (~7y 6m)
RECRUITINGObservational study, no treatment givenUpdated a few months agoNCT04945330

NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

Intervention: Larotrectinib (Vitrakvi, BAY2757556)

Sponsor: Bayer

Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer.

Ages not specified1 location
Started Nov 2021Updated 3 months agoEst. Jun 2029 (~2y 8m)
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Find NTRK Fusion Cancer trials near you, ranked by distance →
Active trial locations58 cities in the US
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Trial Pipeline

Jan 2021 to Oct 2031
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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Patient Communities

Connect with other NTRK Fusion Cancer patients, caregivers, and advocacy groups across Facebook groups, Reddit communities, and YouTube channels. These patient communities offer peer support, shared experiences, caregiver resources, and real-time discussion about NTRK Fusion Cancer treatments, clinical trial participation, and day-to-day disease management.

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Related Rare Cancers Conditions

Other rare diseases in the rare cancers category. Patients with NTRK Fusion Cancer may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

NTRK Fusion Cancer News and Guides

Trial Friend articles about NTRK Fusion Cancer, newest first

Companies Developing NTRK Fusion Cancer Treatments

2 pharmaceutical companies have NTRK Fusion Cancer in their rare disease portfolio

Frequently Asked Questions About NTRK Fusion Cancer