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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. 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.

In plain words, NTRK fusion cancers are a group of rare tumors where one of the NTRK genes gets joined to another gene by mistake. Those joined genes make a faulty protein that drives cells to grow out of control, and this can happen in many kinds of cancer.

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NTRK Fusion Cancer

Where treatments stand, from ClinicalTrials.gov and FDA labels

Also 3 studies with no phase, like observational studies.

FDA review0

No decision pending. FDA calendar

FDA-approved medicines3

Augtyro · Rozlytrek · Vitrakvi

NTRK Fusion Cancer has 3 FDA-approved medicines, 10 open or active clinical trials (9 recruiting), and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

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More about NTRK Fusion Cancer

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).

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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.

What are the symptoms of NTRK Fusion Cancer?

These are common symptoms of NTRK Fusion Cancer, and how strong they are varies from person to person.

  • 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 gets NTRK Fusion Cancer?

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.

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Which medicines are FDA-approved for NTRK Fusion Cancer?

There are currently 3 FDA-approved medications for NTRK Fusion Cancer.

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.

Which new NTRK Fusion Cancer medicines are in trials?

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

How to get help paying for NTRK Fusion Cancer treatment

Charity funds and drugmaker programs for NTRK Fusion Cancer, checked at the source.

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Every program and fund for NTRK Fusion Cancer, by insurance →

Side effects people have reported to the FDA

Side effects people have reported to the FDA

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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Diagnosis and genetic testing

Genetic testing for NTRK Fusion Cancer

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 9 studies recruiting patients and 1 not yet recruiting in the United States and worldwide, with eligibility criteria in plain English. Of these, 7 test a treatment and 3 are observational studies or registries; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map, the pipeline timeline or the medication 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.

10 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+
Started Jul 2012Updated 2 weeks agoEst. Jul 2027 (~8 months)
RecruitingTreatment trialPhase 2Recently updatedNCT06010342

A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients

Intervention: TL118 Capsule

Sponsor: Teligene US

The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions

Ages 18 Years+
Started Mar 2023Updated 2 weeks agoEst. Dec 2027 (~1y 1m)
RecruitingTreatment trialPhase 2Recently updatedNCT05783323

Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

Intervention: Larotrectinib monotherapy, 131I therapy

Sponsor: Children's Hospital of Philadelphia · Bayer

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung meta...

Ages 2 Years to 99 Years
Started Feb 2024Updated 3 weeks agoEst. Oct 2028 (~1y 10m)
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 1 month agoEst. Dec 2027 (~1y 1m)
RecruitingObservational study, no treatment givenUpdated a few months agoNCT07755826

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 3 months agoEst. Apr 2034 (~7y 5m)
Find NTRK Fusion Cancer trials near you, ranked by distance →
Active trial locations22 cities in the US
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Trial Pipeline

Jan 2021 to Nov 2031
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Early Phase 1
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RecruitingNot yet recruitingDelayed startTodayHover a bar for trial details

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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NTRK Fusion Cancer patient communities

Facebook groups, Reddit communities and YouTube channels where NTRK Fusion Cancer patients, caregivers and advocacy groups talk.

NTRK Fusion Cancer news and guides

Trial Friend articles about NTRK Fusion Cancer, newest first

Companies developing NTRK Fusion Cancer treatments

Drugmakers that list NTRK Fusion Cancer in their rare disease portfolio, 2 in all.

Questions people ask about NTRK Fusion Cancer