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Rare Cancers

NTRK Fusion Cancer (NTRK) Clinical Trials and Treatments

Also called NTRK, TRK fusion, neurotrophic tyrosine receptor kinase fusion, 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.

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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 approval of larotrectinib (Vitrakvi, Bayer) and entrectinib (Rozlytrek, Roche/Genentech), the first tissue-agnostic cancer therapies approved based on a molecular marker rather than tumor location. Larotrectinib, originally developed by Loxo Oncology (acquired by Eli Lilly in 2019), is a highly selective TRK inhibitor with response rates of approximately 75% across 17 unique cancer types harboring NTRK fusions in pivotal trials. Larotrectinib received full FDA approval in April 2025, converting from its original 2018 accelerated approval. Bayer holds exclusive global commercial rights to Vitrakvi. Entrectinib (Rozlytrek, Roche/Genentech) is also FDA-approved for TRK fusion-positive solid tumors and ROS1-positive NSCLC, and is CNS-penetrant, offering an additional option particularly for patients with brain metastases. In June 2024, repotrectinib (Augtyro, Bristol Myers Squibb) received FDA approval for NTRK gene fusion-positive solid tumors, becoming the first next-generation TRK inhibitor approved for this indication and offering a treatment option for patients whose tumors develop resistance to larotrectinib or entrectinib. Comprehensive genomic profiling (CGP) through next-generation sequencing is essential for identifying patients who may benefit from these targeted therapies.

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 a dozen different 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.

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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. 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.

TrialsSite mapPipeline timelineMedication checker

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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RECRUITINGRecently 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 – 17 Years2 locations
Started Nov 2025Updated 1 month agoEst. Apr 2034 (~7y 7m)
RECRUITINGPHASE2Recently 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 1 month agoEst. Jul 2027 (~10 months)
RECRUITINGRecently 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 2 months agoEst. Nov 2029 (~3y 2m)
RECRUITINGRecently updatedNCT04945330

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 2 months agoEst. Jun 2029 (~2y 9m)
NOT YET RECRUITINGUpdated a few months agoNCT07599007

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
Started May 2026Updated 4 months agoEst. Dec 2027 (~1y 3m)
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Active trial locations58 cities in the US
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Trial Pipeline

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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.

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