NTRK gene fusion

Fusions involving NTRK1, NTRK2 or NTRK3 detected by sequencing, FISH or pan-TRK immunohistochemistry; used as a tissue-agnostic predictive marker for TRK inhibitors in solid tumors.

CI-BIO-00000023NTRK1 graph →NTRK2 graph →NTRK3 graph →NCIt C183255 Tumor-agnostic · 8 approval rows

Also calledNTRK fusion-positive · TRK fusion · ETV6-NTRK3 · NTRK1/2/3 fusion

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (8)

Entrectinib EU EMA · Jul 31, 2020 · drug + indication textRegulatory approved
Entrectinib US FDA · Oct 20, 2023 · drug + indication textRegulatory approved
Entrectinib US FDA · Aug 15, 2019 · drug + indication textRegulatory approved
Larotrectinib EU EMA · Sep 19, 2019 · drug + indication textRegulatory approved
Larotrectinib US FDA · Nov 26, 2018 · drug + indication textRegulatory approved
Larotrectinib US FDA · Nov 26, 2018 · drug + indication textRegulatory approved
Repotrectinib EU EMA · Jan 13, 2025 · drug + indication text

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (32)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Neoplasm	24	24	—	—	0 / 3 / 1 / 20 / 0
Infantile Fibrosarcoma	13	8	—	5	2 / 2 / 9 / 0 / 0
Solid Neoplasm	13	13	—

Derived

Drugs with predictive evidence (10)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
LarotrectinibSmall Molecule	55	48	7	A	48 / 14	Acute Myeloid Leukemia, Anaplastic Ependymoma, B Lymphoblastic Leukemia/Lymphoma, Breast Secretory Carcinoma +18
EntrectinibSmall Molecule	43	36	7	A	36 / 16	Acute Myeloid Leukemia, Anaplastic Astrocytoma, Brain Glioblastoma, Colorectal Adenocarcinoma +14
RepotrectinibSmall Molecule	4	4	—	C	7 / 0	Lung Non-Small Cell Carcinoma, Malignant Neoplasm
CrizotinibSmall Molecule	4	3	1	C	2 / 2	Infantile Fibrosarcoma, Lung Adenocarcinoma, Malignant Neoplasm
LestaurtinibSmall Molecule	2	2	—	D	2 / 0	Lung Adenocarcinoma, Malignant Colorectal Neoplasm
ALK/TRK Inhibitor TSR-011	1	—	1	D	0 / 2	Malignant Neoplasm
EtoposideSmall Molecule	1	1	—	C	1 / 0	B Lymphoblastic Leukemia/Lymphoma
Larotrectinib Regimen	1	1	—	A	1 / 0	Solid Neoplasm
MethotrexateSmall Molecule	1	1	—	C	1 / 0	B Lymphoblastic Leukemia/Lymphoma
TRK Inhibitor	1	1	—	C	1 / 0	Spindle Cell Sarcoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (105)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 101–105 of 105 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
NTRK1 Fusion1
Larotrectinib	Thyroid Gland Papillary CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID11575 Bragas et al (2022) report a case study of a 50-year old female with a papillary thyroid carcinoma with multiple metastases containing a SQSTM1::NTRK1 fusion treated with larotrectinib. SQSTM1::NTRK1 … (full text at CIViC) PMID 35118995 · Bargas et al., 2022 · Open in CIViC	civic
NTRK1 Fusion1
Larotrectinib	Thyroid Gland Papillary CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID11747 FFPE samples from 351 primary thyroid carcinomas were subjected to targeted gene rearrangement next-generation sequencing, and 11 NTRK rearrangements were found, all with intact kinase domains, and in… (full text at CIViC) PMID 32457407 · Chu et al., 2020 · Open in CIViC	civic
NTRK3 Fusion2
Crizotinib	Mammary Analogue Secretory CarcinomaUNRESOLVED	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID1870 Case report of a patient with mammary analogue secretory carcinoma (MASC) harboring an ETV6-NTRK3 fusion. The patient was treated with crizotinib and had stable disease but disease progression after 1… (full text at CIViC) PMID 26884591 · Drilon et al., 2016 · Open in CIViC	civic
Entrectinib	Mammary Analogue Secretory CarcinomaUNRESOLVED	Predictive	C	Supports Sensitivity Response	3	accepted	EID1869 Case report of a patient with mammary analogue secretory carcinoma (MASC) harboring an ETV6-NTRK3 fusion. The patient was treated with entrectinib and exhibited a partial response for 7 months followe… (full text at CIViC) PMID 26884591 · Drilon et al., 2016 · Open in CIViC	civic
NTRK3 Fusion + NTRK3 G623R1
Entrectinib	Mammary Analogue Secretory CarcinomaUNRESOLVED	Predictive	C	Supports Resistance	4	accepted	EID1874 Case report of a patient with mammary analogue secretory carcinoma (MASC) harboring an etv6-ntrk3 fusion. The patient was treated with entrectinib and exhibited a partial response for 7 months followe… (full text at CIViC) PMID 26884591 · Drilon et al., 2016 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (146)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

emaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Entrectinib	EU EMA	Tumor-agnosticLung Non-Small Cell Carcinoma	Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.conditional	approved	Jul 31, 2020	ema
Larotrectinib	EU EMA	Tumor-agnostic	Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.conditional	approved	Sep 19, 2019	ema
Repotrectinib

Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (93)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 45 recruiting · 29 active phase 3 · 344 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 93 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Sep 29, 2026	clinicaltrials
NCT00092222	Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity	active not recruiting	Phase 2	75	National Cancer Institute (NCI)NIH	1	Sep 28, 2026	clinicaltrials
NCT07843550	A Phase 1/2 Trial Of Larotrectinib And Pembrolizumab In Patients With Solid Tumors Previously Treated With Immune Checkpoint Inhibitor Monotherapy	not yet recruiting	Phase 1 / Phase 2	22	M.D. Anderson Cancer CenterOTHER	1	Sep 28, 2026	clinicaltrials
NCT04094610	A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations	recruiting	Phase 1 / Phase 2	75	Turning Point Therapeutics, Inc.INDUSTRY	11	Sep 25, 2026	clinicaltrials
NCT05663866	Premedication to Reduce Amivantamab Associated Infusion Related Reactions	active not recruiting	Phase 2	68	Janssen Research & Development, LLCINDUSTRY	5	Sep 25, 2026	clinicaltrials
NCT06172296	Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma	recruiting	Phase 3	478	National Cancer Institute (NCI)NIH	5	Sep 24, 2026	clinicaltrials
NCT02194738	Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)	active not recruiting	N/A	7,458	National Cancer Institute (NCI)NIH	3	Sep 23, 2026	clinicaltrials
NCT02650401	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(STARTRK-NG)	active not recruiting	Phase 1 / Phase 2	69	Hoffmann-La RocheINDUSTRY	9	Sep 23, 2026	clinicaltrials
NCT06564844	A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features(TROPION-Lung12)	active not recruiting	Phase 3	25	AstraZenecaINDUSTRY	10	Sep 23, 2026	clinicaltrials
NCT06140836	A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)	active not recruiting	Phase 3	190	Bristol-Myers SquibbINDUSTRY	21	Sep 22, 2026	clinicaltrials
NCT07816380	A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer	not yet recruiting	Phase 3	216	Guangzhou JOYO Pharma Co., LtdINDUSTRY	0	Sep 22, 2026	clinicaltrials
NCT04293562	A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations	recruiting	Phase 3	1,400	Children's Oncology GroupNETWORK	4	Sep 17, 2026	clinicaltrials
NCT05955261	A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia	recruiting	Phase 2	70	St. Jude Children's Research HospitalOTHER	1	Sep 17, 2026	clinicaltrials
NCT04302025	A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)(NAUTIKA1)	recruiting	Phase 2	99	Genentech, Inc.INDUSTRY	1	Sep 10, 2026	clinicaltrials
NCT06315010	Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis(REPOSE)	recruiting	Phase 2	20	MedSIROTHER	3	Sep 9, 2026	clinicaltrials
NCT04092283	Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer	active not recruiting	Phase 3	660	National Cancer Institute (NCI)NIH	2	Sep 8, 2026	clinicaltrials
NCT04589845	Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study	active not recruiting	Phase 2	920	Hoffmann-La RocheINDUSTRY	23	Sep 4, 2026	clinicaltrials
NCT03178552	A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)(B-FAST)	active not recruiting	Phase 2 / Phase 3	1,000	Hoffmann-La RocheINDUSTRY	27	Sep 3, 2026	clinicaltrials
NCT05862285	A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study(UmbrellaMAX)	recruiting	Phase 3	100	Hoffmann-La RocheINDUSTRY	15	Sep 2, 2026	clinicaltrials
NCT06528496	N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma	recruiting	Phase 2	45	Memorial Sloan Kettering Cancer CenterOTHER	1	Aug 28, 2026	clinicaltrials
NCT00334815	Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery	active not recruiting	Phase 2	29	National Cancer Institute (NCI)NIH	1	Aug 26, 2026	clinicaltrials
NCT02176967	Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma	active not recruiting	Phase 3	621	Children's Oncology GroupNETWORK	6	Aug 25, 2026	clinicaltrials
NCT02568267	Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)(STARTRK-2)	active not recruiting	Phase 2	534	Hoffmann-La RocheINDUSTRY	16	Aug 25, 2026	clinicaltrials
NCT03126916	Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)	recruiting	Phase 3	750	Children's Oncology GroupNETWORK	3	Aug 25, 2026	clinicaltrials
NCT07059975	UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML	recruiting	Early Phase 1	36	Baylor College of MedicineOTHER	1	Aug 24, 2026	clinicaltrials
NCT06741644	A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors	recruiting	Phase 1 / Phase 2	800	CStone PharmaceuticalsINDUSTRY	3	Aug 20, 2026	clinicaltrials
NCT02521493	Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome	active not recruiting	Phase 3	280	Children's Oncology GroupNETWORK	6	Aug 19, 2026	clinicaltrials
NCT05624996	Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer	recruiting	Phase 3	474	NRG OncologyOTHER	2	Aug 17, 2026	clinicaltrials
NCT04603807	A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases	active not recruiting	Phase 3	217	Hoffmann-La RocheINDUSTRY	18	Aug 13, 2026	clinicaltrials
NCT04947501	A Study of N9 Chemotherapy in Children With Neuroblastoma	active not recruiting	Early Phase 1	26	Memorial Sloan Kettering Cancer CenterOTHER	1	Aug 7, 2026	clinicaltrials
NCT05170204	A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)(HORIZON 1)	active not recruiting	Phase 3	68	Hoffmann-La RocheINDUSTRY	19	Aug 5, 2026	clinicaltrials
NCT06177067	Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia	recruiting	Phase 1	24	St. Jude Children's Research HospitalOTHER	1	Aug 3, 2026	clinicaltrials
NCT05457556	Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome	active not recruiting	Phase 3	66	Children's Oncology GroupNETWORK	3	Jul 30, 2026	clinicaltrials
NCT03141359	Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC	active not recruiting	Phase 2	61	Wake Forest University Health SciencesOTHER	1	Jul 28, 2026	clinicaltrials
NCT03155620	Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)	active not recruiting	Phase 2	1,377	National Cancer Institute (NCI)NIH	4	Jul 24, 2026	clinicaltrials
NCT02416388	Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR(BIG-1)	recruiting	Phase 2 / Phase 3	3,100	University Hospital, AngersOTHER_GOV	1	Jul 17, 2026	clinicaltrials
NCT06942039	Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation	recruiting	Early Phase 1	15	C17 CouncilOTHER	1	Jul 14, 2026	clinicaltrials
NCT06552234	Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC(REPOROS)	recruiting	Phase 2	30	Centre Hospitalier Intercommunal de Toulon La Seyne sur MerOTHER	1	Jul 7, 2026	clinicaltrials
NCT05722886	DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol(DETERMINE)	recruiting	Phase 2 / Phase 3	825	Cancer Research UKOTHER	1	Jul 1, 2026	clinicaltrials
NCT06813079	Using Tumor Models to Determine Treatments	recruiting	Phase 2	25	University Health Network, TorontoOTHER	1	Jun 23, 2026	clinicaltrials
NCT05525858	KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II(KOSMOSII)	recruiting	—	1,000	Seoul National University Bundang HospitalOTHER	1	Jun 22, 2026	clinicaltrials
NCT03213704	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	9	National Cancer Institute (NCI)NIH	2	Jun 17, 2026	clinicaltrials
NCT03983824	Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia	active not recruiting	Phase 1	48	National Cancer Institute (NCI)NIH	1	Jun 11, 2026	clinicaltrials
NCT01993810	Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	active not recruiting	Phase 3	330	Radiation Therapy Oncology GroupNETWORK	1	Jun 8, 2026	clinicaltrials
NCT03947385	Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions	recruiting	Phase 1 / Phase 2	336	IDEAYA BiosciencesINDUSTRY	3	Jun 8, 2026	clinicaltrials
NCT05004116	A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer	recruiting	Phase 1 / Phase 2	77	Memorial Sloan Kettering Cancer CenterOTHER	1	Jun 4, 2026	clinicaltrials
NCT03093116	A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements(TRIDENT-1)	recruiting	Phase 1 / Phase 2	500	Turning Point Therapeutics, Inc.INDUSTRY	19	May 27, 2026	clinicaltrials
NCT00077285	Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma	active not recruiting	Phase 2	65	Memorial Sloan Kettering Cancer CenterOTHER	1	May 22, 2026	clinicaltrials
NCT02632708	Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation	active not recruiting	Phase 1	153	Institut de Recherches Internationales ServierOTHER	3	May 22, 2026	clinicaltrials
NCT05800587	Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer	recruiting	Phase 2	280	Fox Chase Cancer CenterOTHER	1	May 22, 2026	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Approval rows flagged tumor-agnostic (8)

Associated cancers (32)

Drugs with predictive evidence (10)

Predictive evidence items (105)

Approvals mentioning the linked drugs (146)

Active trials (93)

Linked publications (77)