Gene fusion in ROS1

ROS1 fusion

61 active trials select patients by ROS1 fusion or a broader group, and 34 of them are recruiting. 5 FDA and 3 EU approvals name it.

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

Active trials by phase
Phase 1: 11 active trials111Phase 1/2: 9 active trials1/29Phase 2: 29 active trials229Phase 2/3: 1 active trials2/31Phase 3: 10 active trials310Phase 4: 1 active trials41
Trials started per year (2026 so far)
2010: 0 trials started20102011: 1 trials started2012: 2 trials started2013: 2 trials started2014: 5 trials started2015: 2 trials started20152016: 5 trials started2017: 7 trials started2018: 8 trials started2019: 10 trials started2020: 13 trials started20202021: 14 trials started142022: 6 trials started2023: 7 trials started2024: 10 trials started2025: 7 trials started2026: 4 trials started42026

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
crizotinib
FDA, 2016
metastatic, ROS1-positive Label 1.1 (ALK- or ROS1-positive metastatic NSCLC). Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
EU (EMA), 2016
ROS1-positive advanced NSCLC II/0039, EC decision 25/08/2016. Xalkori MA no longer conditional since 11/11/2016. Source
Xalkori
NSCLC Approved 2016To verify Approved 2016
entrectinib
FDA, 2019
metastatic, ROS1-positive Label 1.1, regular (no AA statement). Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source
EU (EMA), 2020
ROS1-positive advanced NSCLC, not previously treated with ROS1 inhibitors Conditional MA 31/07/2020 (MA still conditional). Source
Rozlytrek
NSCLC Approved 2019To verify Approved 2020 conditional
repotrectinib
FDA, 2023
locally advanced or metastatic, ROS1-positive FDA approval 15/11/2023. Source
EU (EMA), 2025
ROS1-positive advanced NSCLC Conditional MA 13/01/2025. Source
Augtyro
NSCLC Approved 2023 Approved 2025 conditional
taletrectinib
FDA, 2025
locally advanced or metastatic, ROS1-positive FDA approval 11/06/2025; label revised 9/2026. Source
EU (EMA)
ROS1-positive advanced NSCLC No official EMA record found: taletrectinib does not appear in EMA's medicines data (Oct 2026), and EMA does not publish named applications under evaluation there. Only source is a news site; status not verified. Source
Ibtrozi
NSCLC Approved 2025 Under reviewTo verify
zidesamtinib
FDA, 2026
locally advanced or metastatic ROS1-positive, after >=1 prior ROS1 TKI FDA approval 22/07/2026 (announced as an approval, not accelerated). No EU application found. Source
Jideytro
NSCLC Approved 2026 Not approved

Companies

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

  1. Nuvation Bio 4
  2. Roche 4
  3. Bristol Myers Squibb 3
  4. Guangzhou JOYO Pharma 3
  5. CSPC 2
  6. Ascentage Pharma Group 2
  7. Avistone Biotechnology 2
  8. Pfizer 1
  9. AstraZeneca 1
  10. Iovance Biotherapeutics 1
  11. BioNTech 1
  12. L & L Bio Co., Ltd., Ningbo, China 1
  13. Nuvalent 1
  14. Xilio Development 1
  15. Xuanzhu Biopharmaceutical 1

Trials

Matched automatically from registry text, so a few trials may only mention ROS1 fusion rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

Status
Match

61 of 113 trials shown

  1. Lorlatinib Continuation Study

    Active, not recruiting Phase 4 Pfizer Started 2021 NCT05144997

    Lorlatinib

    …TOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL S…

    Non-Small-Cell Lung Cancer, NSCLC

  2. 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 Guangzhou JOYO Pharma Started 2026 NCT07816380

    JYP0322 TabletsCrizotinib Capsules FDA EU

    …dition stage IIIB or IIIC not amenable to multimodality therapy) or metastatic (stage IV) ROS1-positive non-small cell lung cancer (NSCLC).

    NSCLC (Advanced Non-small Cell Lung Cancer)

  3. DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

    Recruiting Phase 2/3 Cancer Research UK Started 2025 NCT05770544

    Entrectinib FDA EU

    Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically val…

    Haematological Malignancy, Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders

  4. Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

    Recruiting Phase 3 AstraZeneca Started 2025 NCT07291037

    Datopotamab deruxtecan (Dato-DXd)Docetaxel

    …tion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations.

    Non-small Cell Lung Cancer (NSCLC)

  5. JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.

    Not yet recruiting Phase 3 Guangzhou JOYO Pharma Started 2025 NCT07154368

    Pemetrexed injectionCross-over to JYP0322JYP0322 tablets

    Locally advanced or metastatic ROS1 fusion positive NSCLC.

    Non Small Cell Lung Cancer

  6. Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

    Recruiting Phase 3 Nuvation Bio Started 2025 NCT07154706

    Taletrectinib FDA

    Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equiva…

    Non-small Cell Lung Cancer (NSCLC)

  7. A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

    Recruiting Phase 3 Nuvation Bio Started 2024 NCT06564324

    Taletrectinib FDACrizotinib FDA EU

    Have documentation of ROS1 rearrangement by a positive result

    Non Small Cell Lung Cancer

  8. Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study

    Recruiting Phase 3 Gustave Roussy, Cancer Campus, Grand Paris Started 2023 NCT05692999

    Pembrolizumab 200 mg Q6WPemetrexed 500 mg/m^2 Q3WPembrolizumab 200 mg Q3W or 400 mg Q6W

    In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line.

    Metastatic Non-squamous Lung Cancer

  9. 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 Bristol Myers Squibb Started 2023 NCT06140836

    Repotrectinib FDA EUCrizotinib FDA EU

    Participant has a ROS1 gene rearrangement/fusion as detected by a local test.

    Carcinoma, Non-Small-Cell Lung

  10. 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)

    Active, not recruiting Phase 3 Roche Started 2022 NCT05170204

    AlectinibEntrectinib FDA EUDurvalumab

    …id-thighs) for the purposes of staging, performed prior and within 42 days for Cohort A2 (ROS1 positive) and 50 days for Cohort A1 (ALK positive) of the first dose of concurrent chemoradiothera…

    Non-Small Cell Lung Cancer

  11. 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 Roche Started 2021 NCT04603807

    Entrectinib FDA EUCrizotinib FDA EU

    … amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.

    Carcinoma, Non-Small-Cell Lung

  12. Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 M.D. Anderson Cancer Center Started 2017 NCT03391869

    IpilimumabNivolumab

    Also, note that patients with ROS1/RET alterations can be enrolled, as tyrosine kinase inhibitor such as crizotinib aren't established as fi…

    Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  13. Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC

    Recruiting Phase 2 Massachusetts General Hospital Started 2026 NCT07405190

    Ivonescimabcarboplatinpemetrexed

    ROS1 fusion: crizotinib, entrectinib, repotrectinib, or taletrectinib iv.

    Lung Cancer (NSCLC), Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer (Non-Small Cell), Lung Cancer - Non Small Cell

  14. Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations

    Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2026 NCT07829744

    Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.

    Lung Cancer (NSCLC)

  15. 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

    Concurrent positive 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

  16. 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

    …h-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

  17. PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC

    Recruiting Phase 2 Guangdong Association of Clinical Trials Started 2026 NCT07416058

    QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

    ALK, ROS1, RET fusions

    Lung Adenocarcinoma

  18. Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases

    Not yet recruiting Phase 2 Bing Xia Started 2026 NCT07875465

    PD-1/PD-L1 inhibitorsCombined Chemotherapy

    Cohort B: Advanced NSCLC with positive driver genes (EGFR/ALK/ROS1), disease progression during first-line targeted therapy.

    Liver Metastases, Non-Small Cell Lung Cancer, Colorectal Cancer (Diagnosis), Pancreatic Cancer Metastatic

  19. 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, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mu…

    Non-squamous Non-small Cell Lung Cancer

  20. Lorlatinib in ROS1+ NSCLC With Brain Metastasis

    Not yet recruiting Phase 2 Hunan Cancer Hospital Started 2025 NCT07083687

    Lorlatinib 100 mg

    Histologically or cytologically confirmed diagnosis of ROS1+ NSCLC with brain metastases before the use of lorlatinib.

    Lung Cancer (NSCLC)

  21. Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis

    Recruiting Phase 2 MedSIR Started 2025 NCT06315010

    Repotrectinib FDA EU

    Patients with confirmed ROS1 rearrangement.

    NSCLC, Brain Metastases, ROS1 Gene Rearrangement

  22. A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1/2 BioNTech Started 2025 NCT07111520

    BNT326Pumitamig

    … one or more actionable genomic alterations: EGFR (other than activating mutations), ALK, ROS1, MET, BRAF, RET, NTRK, HER2, KRAS, or other genomic alterations, with available targeted therapy.

    Non-small Cell Lung Cancer

  23. A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 L & L Bio Co., Ltd., Ningbo, China Started 2024 NCT06468358

    LB1410LB4330

    1. non-squamous NSCLC must have documented test results of EGFR mutation, ALK fusion and ROS1 fusions, and the above driver genes must be wild type;

    Solid Tumor

  24. Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

    Recruiting Phase 2 University of Rochester Started 2024 NCT06262321

    …C) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).

    Stage 4 NSCLC, Radiotherapy

  25. Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

    Recruiting Phase 2 Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Started 2024 NCT06552234

    Repotrectinib FDA EU

    …or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an ROS1 gene rearrangement as by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing …

    NSCLC Stage IV, NSCLC, Stage III

  26. Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative

    Active, not recruiting Phase 2 Qian Chu Started 2023 NCT06001151

    CadonilimabPemetrexedCarboplatin

    Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion

    Carcinoma, Non-Small-Cell Lung

  27. Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer

    Recruiting Phase 2 Pingping Song Started 2023 NCT05765877

    WX-0593 Tablets

    ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM editi…

    Non-Small Cell Lung Cancer(NSCLC)

  28. Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations

    Active, not recruiting Phase 1/2 University of Colorado, Denver Started 2023 NCT05845671

    Amivantamab 1050mgAmivantamab 1400mgAmivantamab (to be determined)Amivantamab (to be determined)

    ROS1 fusions - entrectinib, lorlatinib

    Lung Cancer, Non Small Cell Lung Cancer

  29. 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 previousl…

    Advanced Solid Tumor

  30. 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

    For ROS1 fusion-positive patients: Progression or intolerance on first-line therapy for ROS1 fusion-posit…

    Non Small Cell Lung Cancer

  31. A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

    Recruiting Phase 1/2 Nuvalent Started 2022 NCT05118789

    Zidesamtinib (NVL-520) FDA

    …lly or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.

    Locally Advanced Solid Tumor, Metastatic Solid Tumor

  32. The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer

    Active, not recruiting Phase 2 Yale University Started 2021 NCT04699123

    NC318 800 mgNC318 400 mgPembrolizumab

    Patients with NSCLC known to harbor an ALK rearrangement, ROS1 rearrangement, EGFR mutation or BRAF mutation known to be sensitive to FDA approved tyrosine kinase inh…

    Advanced Non-small Cell Lung Cancer

  33. 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

  34. Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

    Active, not recruiting Phase 2 Intergroupe Francophone de Cancerologie Thoracique Started 2021 NCT04621188

    Lorlatinib

    …(Stage IIIB, IIIC or IV accordingly to 8th classification TNM, UICC 2015) that carries an ROS1 rearrangement, as determined by the molecular biology platform of the investigator by FISH assay or by …

    Non Small Cell Lung Cancer Metastatic

  35. Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

    Active, not recruiting Phase 2 Nuvation Bio Started 2021 NCT04919811

    Taletrectinib FDA

    Evidence of ROS1 fusion by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-ce…

    Non Small Cell Lung Cancer

  36. Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

    Recruiting Phase 2 Iovance Biotherapeutics Started 2021 NCT04614103

    LN-145LN-145

    For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted th…

    Metastatic Non Small Cell Lung Cancer

  37. A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

    Active, not recruiting Phase 2 Nuvation Bio Started 2020 NCT04395677

    AB-106

    Positivity of ROS1 fusion is determined by the local qualified laboratories by using the FISH, RT-PCR or NGS assay,…

    Non Small Cell Lung Cancer

  38. 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

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

    Non-small Cell Lung Cancer

  39. Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

    Active, not recruiting Phase 2 SWOG Cancer Research Network Started 2020 NCT04268550

    Selpercatinib

    This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-…

    Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

  40. 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 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable …

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

  41. 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

    … and/or Tyro3 activating mutations and/or amplification, and/or NTRK translocation and/or ROS1 translocation, and/or MET translocation.

    Malignant Solid Tumor

  42. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020 NCT04423185

    Almonertinib 110 MGDacomitinib 45 MGAlectinib 150 MGCrizotinib 250 MG FDA EUPyrotinib 160/80 MGImatinib 400 MG

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mutation, C-KIT mutation, HE…

    Rare Tumor

  43. Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018 NCT03213652

    Ensartinib

    …ractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

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

  44. 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

    EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii.

    Locally Advanced Solid Tumors, Metastatic Solid Tumors

  45. 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

  46. Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015 NCT04439253

    Crizotinib FDA EU

    Patients must be positive for translocation or inversion events involving the ROS1 gene via the MATCH Master Protocol

    Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma

  47. 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

    Group C: ROS1 fusion

    Non-Small Cell Lung Cancer

  48. 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

  49. A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 Avistone Biotechnology Started 2024 NCT06307795

    ANS014004

    With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation

    Locally Advanced or Metastatic Solid Tumors

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

    Recruiting Phase 1 CSPC Started 2024 NCT07110883

    SYS6023

    … Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, serine/threonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosin…

    Advanced Solid Tumor

  51. APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

    Recruiting Phase 1 Ascentage Pharma Group Started 2024 NCT06687070

    APG -2449PLD

    Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

    Platinum-resistant Recurrent Ovarian Cancer, Advanced Solid Tumor

  52. Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

    Recruiting Phase 1 Guangzhou JOYO Pharma Started 2022 NCT06128148

    JYP0322 50 mg qdJYP0322 100 mg qdJYP0322 200 mg qdJYP0322 100 mg bidJYP0322 150 mg bidJYP0322 200 mg bid

    Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

    Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms

  53. Personalized DC Vaccines in Non Small Cell Lung Cancer

    Active, not recruiting Phase 1 Centre Hospitalier Universitaire Vaudois Started 2022 NCT05195619

    Autologous dendritic cell vaccine loaded with personalized peptides (PEP-DC vaccine)Low dose cyclophosphamide

    …er such as Epidermal Growth Factor Receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS-1-rearrangement, currently receiving osimertinib, alectinib, lorlatinib, brigatinib or crizotinib as per …

    Non-small Cell Lung Cancer

  54. Intrathecal Double Checkpoint Inhibition

    Active, not recruiting Phase 1 University of Zurich Started 2022 NCT05598853

    intrathecal nivolumab and intrathecal ipilimumab

    …ion (exon 19-del and 21-L858R), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene-1 (ROS1) rearrangement.

    Leptomeningeal Metastasis, Non-small Cell Lung Cancer Stage IV, Melanoma Stage IV

  55. TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 1 Shenzhen TargetRx Started 2021 NCT05441956

    TGRX-326

    Diagnosis of ALK-positive or ROS1-positive advanced NSCLC by histopathology or cytology in a Grade-A tertiary hospital or central la…

    Non-small Cell Lung Cancer

  56. DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2020 NCT04042701

    Trastuzumab deruxtecan (DS-8201a)Trastuzumab deruxtecan (DS-8201a)Pembrolizumab

    …actor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK), BRAF V600E mutation, or ROS1 fusion should have disease progression after treatment with at least one genomically-targeted th…

    Breast Cancer, Non-small Cell Lung Carcinoma

  57. APG-2449 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Ascentage Pharma Group Started 2019 NCT03917043

    APG-2449

    …e: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, e…

    Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer

  58. 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

    Driver genes alterations must be negative (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutation, RET rearrangement…

    Broad match: ROS1 fusionStatus may be outdated, last updated 2024-07-29Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression

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

    Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024 NCT06440954

    Intrathecal pemetrexed

    EGFR mutant, ALK fusion, ROS1 fusion, and other oncogenic alterations including RET fusion, BRAF mutation, NTRK fusion, KRAS m…

    Broad match: ROS1 fusionStatus may be outdated, last updated 2024-06-04Non-Small Cell Lung Cancer

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

    Recruiting Phase 2 Sun Yat-sen University Started 2024 NCT06563999

    SunvozertinibCrizotinib FDA EUPralsetinibLarotrectinibSavolitinibPyrotinib

    Subjects should have a rare 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: ROS1 fusionLung Cancer Stage III, Mutation

  61. 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

    For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations…

    Broad match: ROS1 fusionMalignancies, Solid Malignant Tumor, NHL (Non-Hodgkin Lymphoma), Solid Tumor Cancer