Gene fusion in NTRK1 and NTRK2 and NTRK3

NTRK1/2/3 fusion

36 active trials select patients by NTRK1/2/3 fusion or a broader group, and 25 of them are recruiting. 3 FDA and 3 EU approvals name it.

Trials as of 2026-10-27. Seen most often in tumor-agnostic.

Active trials by phase
Phase 1: 4 active trials14Phase 1/2: 10 active trials1/210Phase 2: 20 active trials220Phase 4: 1 active trials41N/A: 1 active trialsNo phase1
Trials started per year (2026 so far)
2010: 0 trials started20102011: 0 trials started2012: 1 trials started2013: 0 trials started2014: 2 trials started2015: 2 trials started20152016: 3 trials started2017: 6 trials started2018: 1 trials started2019: 1 trials started2020: 6 trials started20202021: 9 trials started92022: 2 trials started2023: 6 trials started2024: 6 trials started2025: 4 trials started2026: 3 trials started32026

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Open a row for the exact indication and source.

TherapyTumourUnited StatesEuropean Union
entrectinib
FDA, 2019
NTRK gene fusion, no known acquired resistance mutation, adults and children >1 month AA 15/08/2019 (age >=12), expanded to >1 month by AA 20/10/2023; still accelerated (label 1.2, FDA Ongoing list). Source
EU (EMA), 2020
NTRK gene fusion, no prior NTRK inhibitor, no satisfactory alternatives Conditional MA 31/07/2020. Age extended to >=1 month by X/0017/G (EC 27/06/2024), but the EPAR web page indication text still says >=12 years. Check the SmPC. Source
Rozlytrek
solid tumours (tumour-agnostic) Approved 2019 accelerated Approved 2020 conditional
larotrectinib
FDA, 2018
NTRK gene fusion, no acquired resistance mutation, no satisfactory alternatives AA 26/11/2018, converted to regular approval 09/04/2025 (FDA Verified clinical benefit list). The DailyMed label reached (revised 12/2018) is outdated and still shows the accelerated-approval statement. Source
EU (EMA), 2019
NTRK gene fusion, no satisfactory alternatives Conditional MA 19/09/2019. Source
Vitrakvi
solid tumours (tumour-agnostic) Approved 2018 Approved 2019 conditional
repotrectinib
FDA, 2024
NTRK gene fusion, age >=12 AA 13/06/2024; still on FDA Ongoing accelerated approvals list (label 1.2). Source
EU (EMA), 2025
NTRK gene fusion, age >=12, after an NTRK inhibitor or limited other options Conditional MA 13/01/2025. Source
Augtyro
solid tumours (tumour-agnostic) Approved 2024 accelerated Approved 2025 conditional

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. CSPC 2
  2. Roche 2
  3. Bristol Myers Squibb 2
  4. Lantern Pharma 1
  5. Teligene US 1
  6. Anbogen Therapeutics 1
  7. Bayer 1
  8. Beijing InnoCare Pharma Tech 1
  9. VM Oncology 1
  10. Xilio Development 1
  11. Xuanzhu Biopharmaceutical 1
  12. Avistone Biotechnology 1
  13. Jecho Biopharmaceuticals 1
  14. Shenzhen NewDEL Biotech 1

Trials

Matched automatically from registry text, so a few trials may only mention NTRK1/2/3 fusion rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

Status
Match

36 of 55 trials shown

  1. Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

    Not yet recruiting Phase 4 Fujian Medical University Started 2025 NCT07010393

    DabrafenibTrametinibSelpercatinibPralsetinibLenvatinibLarotrectinib FDA EU

    NTRK1/2/3 fusion

    Thyroid Neoplasms

  2. Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

    Recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2026 NCT07483983

    ASP3082

    …ve known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the available targeted therapy and have experienced disease progress…

    Metastatic/Locally Advanced Non-Small-Cell Lung Cancer, Metastatic/Locally Pancreatic Ductal Adenocarcinoma

  3. Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study

    Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026 NCT07365410

    FurmonertinibFurmonertinibcarboplatinpemetrexed

    …sitive for other driver genes (ALK fusion, ROS1 fusion, RET rearrangement, BRAF mutation, NTRK fusion, MET mutation, KRAS mutation)

    Non-small Cell Lung Cancer (NSCLC), Brain Metastases, Furmonertinib, EGFR Mutation

  4. Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors

    Recruiting Phase 2 St. Jude Children's Research Hospital Started 2026 NCT06528691

    Entrectinib FDA EUCyclophosphamideEtoposideCarboplatinG-CSFPegfilgrastim

    High-grade glioma (World Health Organization \[WHO\] grade III or IV) harboring NTRK1/2/3 or ROS1 gene fusions as determined by central pathology review

    High Grade Glioma, CNS Tumor

  5. Phase II Clinical Study of JS207 (PD-1/VEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy

    Recruiting Phase 2 Shanghai Junshi Bioscience Started 2025 NCT06868836

    JS207PemetrexedCarboplatin or cisplatinJS212

    …mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 ex…

    Non-squamous Non-small Cell Lung Cancer

  6. A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC

    Recruiting Phase 1/2 Anbogen Therapeutics Started 2025 NCT07244705

    ABT-301TislelizumabBevacizumab (Avastin)

    NOTE: Participants with BRAF V600E, HER2 amplification/ mutation, KRAS G12C mutation, NTRK gene fusion, RET fusion, may or may not have received relevant targeted therapy and failed.

    Colorectal Cancer (Diagnosis), Colorectal Cancer Metastatic, Colorectal Cancer (CRC), Immunotherapy

  7. Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06547203

    CetuximabToripalimabIrinotecan

    …including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.

    Status may be outdated, last updated 2024-08-09Colorectal Cancer Metastatic

  8. Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

    Recruiting Phase 2 Children's Hospital of Philadelphia Started 2024 NCT05783323

    Larotrectinib monotherapy FDA EU

    Identification of an neurotrophic tyrosine receptor kinase (NTRK) (NTRK1, NTRK2, or NTRK3) gene fusion in a CLIA/CAP accredited laboratory without known kinase domain resistance mutation

    Differentiated Thyroid Cancer, Pediatric Cancer, Cancer, Cancer, Thyroid

  9. A Study of Avutometinib and Defactinib in People With Thyroid Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023 NCT06007924

    AvutometinibDefactinib

    … one of the following genetic alterations: RAS mutation, NF1 mutation, RET rearrangement, NTRK rearrangement, ALK rearrangement, Class 2 or 3 BRAF alterations (non-V600E/K mutations or rearrangement…

    Thyroid Cancer

  10. XTX301 in Patients With Advanced Solid Tumors

    Recruiting Phase 1/2 Xilio Development Started 2023 NCT05684965

    XTX301

    ROS1 fusion, NTRK fusion, BRAF V600E mutation, EGFR mutation, or ALK fusion) must have been previously treated wit…

    Advanced Solid Tumor

  11. A Phase 1/2 Study of CG001419 Tablets in Adult Subjects With Locally Advanced or Metastatic Solid Tumours Harbouring NTRK Gene Abnormalities

    Recruiting Phase 1/2 Cullgen (Shanghai),Inc Started 2023 NCT07394374

    CG001419 tablets

    …mandatory, enrollment priority will be accorded to patients whose tumors harbor oncogenic NTRK/TRK alterations.

    Solid Tumors Harboring NTRK Fusion, NTRK, NTRK Gene Fusion, NTRK Fusion Positive

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

    Recruiting Phase 2 Teligene US Started 2023 NCT06010342

    TL118 Capsule

    …gically confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted to translate into a fusion protein with a functional tropomyosin recept…

    Solid Tumor

  13. Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

    Recruiting Phase 1/2 Beijing InnoCare Pharma Tech Started 2022 NCT05745623

    ICP-723

    …ients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor…

    Advanced Solid Tumors Harboring NTRK Fusion, Primary Central Nervous System Tumors Harboring NTRK Fusion

  14. Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Li Zhang, MD Started 2022 NCT05003037

    Surufatinib, Toripalimab, Pemetrexed, Carboplatin/Cisplatin

    …RBB2 (HER2) amplification/mutation, MET amplification, MET exon 14 skipping mutation, and NTRK fusion.

    Non Small Cell Lung Cancer

  15. A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 Xuanzhu Biopharmaceutical Started 2021 NCT04996121

    XZP-5955 tablets

    Priority will be given to patients who have previously documented NTRK or ROS1 gene fusion confirmed by the central laboratory

    Status may be outdated, last updated 2022-08-30Locally Advanced or Metastatic Solid Tumors, Locally Advanced or Metastatic Non-small Cell Lung Cancer

  16. Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2021 NCT04940325

    DS-1062a

    Participants who have known EGFR, BRAF, and MET mutation or ALK, ROS1, RET, NTRK fusion: one line of an approved targeted agent and one platinum-doublet regimen

    Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer, Unresectable Non-small Lung Cancer

  17. A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 2 Roche Started 2020 NCT04302025

    AlectinibEntrectinib FDA EUVemurafenibCobimetinibPralsetinibAtezolizumab

    …atories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion

    Non-small Cell Lung Cancer

  18. A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2020 NCT04094610

    Oral repotrectinib (TPX-0005) FDA EU

    Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are trop…

    Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors

  19. A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

    Recruiting Phase 2 Centre Leon Berard Started 2020 NCT04116541

    HDM201RibociclibCabozantinibAlectinibRegorafenibTrametinib

    …ET, ROS1, MER, TRKB, TIE-2 and/or Tyro3 activating mutations and/or amplification, and/or NTRK translocation and/or ROS1 translocation, and/or MET translocation.

    Malignant Solid Tumor

  20. Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

    Active, not recruiting Phase 2 Children's Oncology Group Started 2019 NCT03834961

    Larotrectinib Sulfate FDA EU

    …ients must have a histologic diagnosis of infantile fibrosarcoma with an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Act/College of American Pathologists (CLI…

    Central Nervous System Neoplasm, Infantile Fibrosarcoma, Recurrent Acute Leukemia, Refractory Acute Leukemia

  21. VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma

    Recruiting Phase 1/2 VM Oncology Started 2018 NCT03556228

    VMD-928 100 mg TabletVMD-928 Tablet and Pembrolizumab (200 mg)

    (B) any NTRK1 gene fusion positive ("NTRK1+") solid tumors or lymphomas, that is relapsed, refractory or intolerant…

    Head and Neck Carcinoma, Adenoid Cystic Carcinoma, Lung Cancer, Non-Small Cell Lung Cancer

  22. A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2017 NCT03093116

    Oral repotrectinib (TPX-0005) FDA EU

    …e IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.

    Locally Advanced Solid Tumors, Metastatic Solid Tumors

  23. Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017 NCT06390852

    Larotrectinib FDA EU

    Patients must have a malignancy harboring an NTRK1, NTRK2 or NTRK3 gene fusion, as determined by the MATCH screening assessment

    Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm

  24. Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2017 NCT03213704

    Larotrectinib Sulfate FDA EU

    … or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

    Advanced Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Glioma

  25. Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

    Active, not recruiting Phase 1/2 Roche Started 2016 NCT02650401

    Entrectinib FDA EU

    Part B: Primary brain tumors with NTRK1/2/3 or ROS1 gene fusions

    Solid Tumors, CNS Tumors

  26. A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children

    Active, not recruiting Phase 1/2 Bayer Started 2015 NCT02637687

    Larotrectinib (Vitrakvi, BAY2757556) FDA EU

    OR Infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies, and for which no standar…

    Solid Tumors Harboring NTRK Fusion

  27. 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

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2012 NCT01639508

    Cabozantinib

    NTRK fusion iii.

    Non-Small Cell Lung Cancer

  28. A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 Avistone Biotechnology Started 2025 NCT06716138

    ANS03

    With documentation of ROS1 or NTRK alteration

    Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

  29. A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 CSPC Started 2024 NCT07110883

    SYS6023

    …ene, serine/threonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, Neurotrophic Tyrosine Receptor Kinase (RET) rearrangement, HER2 mutation, MET Proto-Onco…

    Advanced Solid Tumor

  30. An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of ND-003 in Patients With Advanced Solid Cancers

    Enrolling by invitation Phase 1 Shenzhen NewDEL Biotech Started 2024 NCT06169579

    ND-003 tabletsND-003 tabletsND-003 tabletsND-003 tabletsND-003 tabletsND-003 tablets

    However, in the dose expansion phase, subjects must have confirmed NTRK or RET gene fusion/mutation (histologic or cytological genetic testing results are acceptable) .

    Advanced Solid Tumor

  31. Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients

    Recruiting No phase Royal Marsden NHS Foundation Trust Started 2025 NCT07673861

    …ified targetable mutation (IDH1 mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR deficiency \[dMMR\]), AND

    Non Small Cell Lung Cancer, Gastrointestinal Stromal Tumor (GIST), Colorectal Cancer, Biliary Tract Cancer

  32. A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel(Albumin Bound)Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer

    Not yet recruiting Phase 2 CSPC Started 2024 NCT06525350

    Glumetinib tabletsHB1801 (docetaxel, albumin-bound)Docetaxel

    …ive (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutation, RET rearrangement, HER2 Mutations, KRAS activation mutati…

    Broad match: NTRK1/2/3 fusionStatus may be outdated, last updated 2024-07-29Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression

  33. Efficacy and Resistance Mechanisms of IP in NSCLC With Leptomeningeal Metastases

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024 NCT06440954

    Intrathecal pemetrexed

    …fusion, ROS1 fusion, and other oncogenic alterations including RET fusion, BRAF mutation, NTRK fusion, KRAS mutation was confirmed by an accredited local laboratory.

    Broad match: NTRK1/2/3 fusionStatus may be outdated, last updated 2024-06-04Non-Small Cell Lung Cancer

  34. Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06563999

    SunvozertinibCrizotinibPralsetinibLarotrectinib FDA EUSavolitinibPyrotinib

    …re mutation based on NGS, including mutations of EGFR exon20ins, ROS1 fusion, RET fusion, NTRK fusion, MET 14 exon, HER2, BRAF V600E, KRAS G12C, and ALK fusion.

    Broad match: NTRK1/2/3 fusionLung Cancer Stage III, Mutation

  35. A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

    Recruiting Phase 2 Lantern Pharma Started 2023 NCT05456256

    LP-300PemetrexedCarboplatin

    …se (ALK), epidermal growth factor receptor (EGFR), neurotrophic tyrosine receptor kinase (NTRK) fusions, etc.).

    Broad match: NTRK1/2/3 fusionAdenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

  36. JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

    Recruiting Phase 1 Jecho Biopharmaceuticals Started 2026 NCT07603479

    JL19001, subcutaneous injection, 1 μg/kgJL19001, subcutaneous injection, 5 μg/kgJL19001, subcutaneous injection,10 μg/kgJL19001, subcutaneous injection,15 μg/kgJL19001, subcutaneous injection,20 μg/kgJL19001, subcutaneous injection,25 μg/kg

    …ith driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations, or HER2mutations): Prior treatm…

    Broad match: NTRK1/2/3 fusionMalignancies, Solid Malignant Tumor, NHL (Non-Hodgkin Lymphoma), Solid Tumor Cancer