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    BIOMARKER:

    ROS1 rearrangement

    i
    Entrez ID:
    6098
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Apply
    Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (ENDURE) (NCT04892953)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    07/07/2021
    Primary completion :
    09/30/2026
    Completion :
    09/30/2026
    EGFR • ALK • MET • RET • ROS1
    |
    RET fusion • ALK rearrangement • MET exon 14 mutation • ALK fusion • ROS1 fusion • ROS1 rearrangement • RET rearrangement
    |
    carboplatin • Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • pemetrexed • Pemfexy (pemetrexed)
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (NCT05943795)
    Phase 3
    Sichuan Baili Pharmaceutical Co., Ltd.
    Recruiting
    Last update posted :
    02/11/2025
    Initiation :
    07/14/2023
    Primary completion :
    07/01/2026
    Completion :
    07/01/2026
    EGFR • HER-2 • KRAS • BRAF • ALK • ROS1 • NTRK
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • RET rearrangement • KRAS G12 • KRAS amplification • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2) (NCT05989542)
    Phase 3
    Beijing Pearl Biotechnology Limited Liability C...
    Recruiting
    Last update posted :
    02/06/2025
    Initiation :
    06/29/2023
    Primary completion :
    09/30/2026
    Completion :
    09/30/2027
    EGFR • KRAS • ALK • MET • ROS1
    |
    ALK rearrangement • EGFR wild-type • MET exon 14 mutation • ROS1 rearrangement
    |
    bozitinib (APL-101)
    Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung (NCT03808662)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Active, not recruiting
    Last update posted :
    02/05/2025
    Initiation :
    01/16/2019
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    EGFR • HER-2 • ER • ALK • ROS1
    |
    ALK rearrangement • ROS1 rearrangement
    Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations (AVANZAR) (NCT05687266)
    Phase 3
    AstraZeneca
    Active, not recruiting
    Last update posted :
    01/30/2025
    Initiation :
    12/29/2022
    Primary completion :
    11/01/2027
    Completion :
    11/01/2027
    EGFR • BRAF • ALK • ROS1 • TACSTD2
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan) • Pemfexy (pemetrexed)
    Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E) (NCT04585477)
    Phase 2
    Stanford University
    Recruiting
    Last update posted :
    01/28/2025
    Initiation :
    04/08/2021
    Primary completion :
    12/30/2025
    Completion :
    12/30/2026
    PD-L1 • ALK • ROS1
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • EGFR L858R • EGFR exon 19 deletion • EGFR expression • ALK rearrangement • ROS1 rearrangement • EGFR positive
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel
    Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer (NCT02321501)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    06/10/2024
    Initiation :
    06/22/2016
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    ROS1
    |
    ALK positive • ROS1 rearrangement
    |
    everolimus • Zykadia (ceritinib)
    A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. (eVOLVE-Lung02) (NCT05984277)
    Phase 3
    AstraZeneca
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    10/24/2023
    Primary completion :
    05/30/2028
    Completion :
    05/16/2029
    EGFR • PD-L1 • ALK • ROS1
    |
    ALK rearrangement • PD-L1 negative • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • volrustomig (MEDI5752)
    The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NCT04699123)
    Phase 2
    Yale University
    Recruiting
    Last update posted :
    05/24/2024
    Initiation :
    02/04/2021
    Primary completion :
    06/30/2025
    Completion :
    06/30/2025
    EGFR • BRAF • ROS1
    |
    PD-L1 expression • EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • NC318
    MGD019 DART® Protein in Unresectable/Metastatic Cancer (NCT03761017)
    Phase 1
    MacroGenics
    Active, not recruiting
    Last update posted :
    05/09/2024
    Initiation :
    12/12/2018
    Primary completion :
    07/01/2024
    Completion :
    12/01/2024
    BRAF • ALK • MSI • ROS1
    |
    EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    lorigerlimab (MGD019)
    SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer (NCT05570825)
    Phase 2
    University of Washington
    Recruiting
    Last update posted :
    05/07/2024
    Initiation :
    04/06/2023
    Primary completion :
    07/01/2027
    Completion :
    07/01/2028
    PD-L1 • ALK • RET • ROS1
    |
    PD-L1 expression • RET fusion • ALK rearrangement • ROS1 fusion • ROS1 rearrangement • RET rearrangement
    |
    Keytruda (pembrolizumab) • SX-682 • Pembroria (pembrolizumab biosimilar)
    Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR) (NCT03833440)
    Phase 2
    Assistance Publique Hopitaux De Marseille
    Active, not recruiting
    Last update posted :
    05/03/2024
    Initiation :
    10/08/2019
    Primary completion :
    10/01/2024
    Completion :
    02/01/2025
    EGFR • ALK • ROS1
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Imfinzi (durvalumab) • docetaxel • Orpathys (savolitinib) • ceralasertib (AZD6738) • oleclumab (MEDI9447) • monalizumab (IPH2201)
    Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC (IOSI-LUNG-001) (NCT04549428)
    Phase 2
    Oncology Institute of Southern Switzerland
    Active, not recruiting
    Last update posted :
    04/22/2024
    Initiation :
    10/01/2020
    Primary completion :
    01/23/2023
    Completion :
    12/31/2024
    ALK • ROS1
    |
    ALK fusion • ROS1 rearrangement
    |
    Tecentriq (atezolizumab)
    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) (NCT02568267)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    03/28/2024
    Initiation :
    11/19/2015
    Primary completion :
    12/31/2024
    Completion :
    04/01/2025
    ROS1 • NTRK1 • NTRK3 • NTRK2
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Rozlytrek (entrectinib)
    A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) (NCT05118789)
    Phase 1/2
    Nuvalent Inc.
    Recruiting
    Last update posted :
    03/08/2024
    Initiation :
    01/04/2022
    Primary completion :
    10/31/2025
    Completion :
    10/31/2026
    ROS1
    |
    ROS1 rearrangement
    |
    zidesamtinib (NVL-520)
    A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (NCT05787613)
    Phase 2
    Shanghai Henlius Biotech
    Recruiting
    Last update posted :
    02/22/2024
    Initiation :
    07/10/2023
    Primary completion :
    07/01/2025
    Completion :
    07/01/2027
    PD-L1 • ROS1 • LAG3
    |
    PD-L1 expression • ROS1 rearrangement • LAG3 expression
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Hetronifly (serplulimab) • HLX26
    Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC (LUN 17-139) (NCT03786692)
    Phase 2
    Fox Chase Cancer Center
    Recruiting
    Last update posted :
    02/12/2024
    Initiation :
    09/04/2019
    Primary completion :
    01/01/2025
    Completion :
    01/01/2027
    PD-L1 • ALK • ROS1
    |
    EGFR mutation • ALK rearrangement • EGFR exon 21 mutation • ROS1 rearrangement • EGFR exon 18 mutation
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • pemetrexed
    Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer (NCT03377023)
    Phase 1/2
    H. Lee Moffitt Cancer Center and Research Insti...
    Active, not recruiting
    Last update posted :
    01/25/2024
    Initiation :
    02/02/2018
    Primary completion :
    11/28/2024
    Completion :
    11/01/2025
    EGFR • BRAF • ALK
    |
    BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • nintedanib
    Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) (NCT04621188)
    Phase 2
    Intergroupe Francophone de Cancerologie Thoracique
    Recruiting
    Last update posted :
    12/19/2023
    Initiation :
    03/19/2021
    Primary completion :
    03/01/2025
    Completion :
    01/01/2026
    ROS1
    |
    ROS1 rearrangement
    |
    Lorbrena (lorlatinib)
    A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NCT05949606)
    Phase 1/2
    Sichuan Baili Pharmaceutical Co., Ltd.
    Recruiting
    Last update posted :
    11/29/2023
    Initiation :
    10/30/2023
    Primary completion :
    11/01/2025
    Completion :
    11/01/2025
    HER-2 • KRAS • BRAF • ALK • MET • ROS1 • NTRK
    |
    BRAF mutation • BRAF V600 • EGFR wild-type • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    izalontamab (SI-B001) • danvilostomig (SI-B003)
    Pembrolizumab and Trametinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer and KRAS Gene Mutations (NCT03299088)
    Phase 1
    University of California, Davis
    Active, not recruiting
    Last update posted :
    09/22/2023
    Initiation :
    06/26/2018
    Primary completion :
    01/28/2021
    Completion :
    06/01/2024
    PD-L1 • KRAS • ALK • ROS1
    |
    KRAS mutation • EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib)
    A Study of DB-1311 in Advanced/Metastatic Solid Tumors (NCT05914116)
    Phase 1/2
    DualityBio Inc.
    Recruiting
    Last update posted :
    09/12/2023
    Initiation :
    09/05/2023
    Primary completion :
    04/01/2025
    Completion :
    04/01/2025
    EGFR • KRAS • BRAF • ALK • MET • ROS1 • NTRK1 • NTRK3 • NTRK2 • CD276
    |
    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • NTRK1 mutation • NTRK3 mutation
    |
    BNT324
    Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers (NCT04712877)
    Phase N/A
    Lung Cancer Mutation Consortium
    Recruiting
    Last update posted :
    09/12/2023
    Initiation :
    06/15/2022
    Primary completion :
    06/15/2024
    Completion :
    06/15/2025
    EGFR • HER-2 • BRAF • ALK • TMB • MET • RET • ROS1 • NTRK
    |
    BRAF V600E • EGFR mutation • HER-2 amplification • BRAF V600 • MET amplification • ALK rearrangement • MET exon 14 mutation • RET mutation • ROS1 rearrangement • MET mutation • RET rearrangement • MET amplification + MET Exon 14 mutation
    OT-101 in Combination With Atezolizumab for the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NCT05935774)
    Phase 2
    University of Washington
    Withdrawn
    Last update posted :
    08/25/2023
    Initiation :
    12/01/2023
    Primary completion :
    07/31/2028
    Completion :
    07/31/2028
    HER-2 • BRAF • ALK • RET • ROS1 • CD4 • NTRK
    |
    BRAF mutation • HER-2 mutation • RET fusion • ALK rearrangement • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    Tecentriq (atezolizumab) • trabedersen (OT-101)
    Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC (NCT04081688)
    Phase 1
    Rutgers, The State University of New Jersey
    Active, not recruiting
    Last update posted :
    07/25/2023
    Initiation :
    09/11/2019
    Primary completion :
    04/27/2022
    Completion :
    04/30/2024
    BRAF • ALK • ROS1 • LAG3 • IDO1 • CD27
    |
    BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    Tecentriq (atezolizumab) • varlilumab (CDX 1127)
    Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR-BioMarkers (BM) Profiling) (NCT03493581)
    Phase N/A
    Assistance Publique Hopitaux De Marseille
    Active, not recruiting
    Last update posted :
    06/26/2023
    Initiation :
    03/08/2018
    Primary completion :
    03/08/2024
    Completion :
    08/12/2024
    EGFR • PD-L1 • ALK • ROS1 • MCAM
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    Study of Crizotinib for ROS1 and MET Activated Lung Cancer (NCT04084717)
    Phase 2
    University Health Network, Toronto
    Recruiting
    Last update posted :
    06/16/2023
    Initiation :
    12/03/2019
    Primary completion :
    12/01/2024
    Completion :
    06/01/2025
    MET • ROS1
    |
    MET amplification • MET exon 14 mutation • ROS1 rearrangement • MET mutation
    |
    Xalkori (crizotinib)
    A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations (NCT01970865)
    Phase 1/2
    Pfizer
    Completed
    Last update posted :
    06/07/2023
    Initiation :
    01/08/2014
    Primary completion :
    03/15/2017
    Completion :
    05/24/2023
    ALK
    |
    ALK positive • ALK rearrangement • ALK mutation • ROS1 positive • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Lorbrena (lorlatinib)
    Exemestane in Post-Menopausal Women With NSCLC (NCT02666105)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Completed
    Last update posted :
    05/31/2023
    Initiation :
    09/27/2018
    Primary completion :
    02/28/2022
    Completion :
    02/28/2022
    ER • ALK • ROS1
    |
    ALK rearrangement • ROS1 rearrangement • EGFR rearrangement
    |
    exemestane
    Personalized DC Vaccines in Non Small Cell Lung Cancer (NCT05195619)
    Phase 1
    Centre Hospitalier Universitaire Vaudois
    Recruiting
    Last update posted :
    05/29/2023
    Initiation :
    12/10/2021
    Primary completion :
    09/01/2024
    Completion :
    09/01/2024
    EGFR • ALK • ROS1
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Opdivo (nivolumab) • Xalkori (crizotinib) • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • cyclophosphamide
    UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC (NCT04940637)
    Phase 2
    University of Turin, Italy
    Recruiting
    Last update posted :
    05/12/2023
    Initiation :
    12/23/2020
    Primary completion :
    06/30/2024
    Completion :
    06/30/2025
    EGFR • PD-L1 • ALK • ROS1 • HRD
    |
    PD-L1 expression • HRD • ALK rearrangement • ROS1 rearrangement
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study (Pulse) (NCT05692999)
    Phase 3
    Gustave Roussy, Cancer Campus, Grand Paris
    Recruiting
    Last update posted :
    04/04/2023
    Initiation :
    03/20/2023
    Primary completion :
    01/01/2029
    Completion :
    01/01/2029
    EGFR • ALK • ROS1 • PD-1 • IL2
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • pemetrexed
    Chemotherapy Combines With Bevacizumab and PD-1 Inhibitor in Non-squamous NSCLC (NCT05267366)
    Phase 2
    Qingdao Central Hospital
    Recruiting
    Last update posted :
    03/29/2023
    Initiation :
    02/01/2022
    Primary completion :
    02/01/2024
    Completion :
    07/01/2024
    ALK • ROS1
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • cisplatin • carboplatin • pemetrexed
    Chemo-immunotherapy Induction Followed by Hypo-radiotherapy in LA-NSCLC(CHIC) (NCT05784142)
    Phase 2
    Jiangsu Cancer Institute & Hospital
    Active, not recruiting
    Last update posted :
    03/24/2023
    Initiation :
    10/27/2022
    Primary completion :
    12/01/2024
    Completion :
    12/01/2027
    EGFR • ALK • ROS1
    |
    ALK rearrangement • ROS1 rearrangement
    Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations (CAPLAND) (NCT04811001)
    Phase 2
    Fondazione Ricerca Traslazionale
    Recruiting
    Last update posted :
    02/21/2023
    Initiation :
    06/12/2020
    Primary completion :
    12/31/2023
    Completion :
    12/31/2023
    EGFR • HER-2 • BRAF • ALK • MET • ROS1
    |
    EGFR mutation • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ALK rearrangement • EGFR L861Q • ALK mutation • ROS1 rearrangement • MET mutation • EGFR S768I • EGFR G719A • EGFR G719S • EGFR G719C
    |
    Tagrisso (osimertinib) • Vizimpro (dacomitinib)
    Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant, ALK- and ROS1-rearranged (NCT05116618)
    Phase N/A
    University of Colorado, Denver
    Withdrawn
    Last update posted :
    09/21/2022
    Initiation :
    01/06/2022
    Primary completion :
    09/15/2022
    Completion :
    09/15/2022
    EGFR • ALK • ROS1
    |
    EGFR mutation • ALK rearrangement • ALK mutation • ROS1 rearrangement • ROS1 mutation • ALK amplification
    Study of Lorlatinib in ROS1 Rearranged NSCLC (NCT03612154)
    Phase 2
    National Cancer Center, Korea
    Recruiting
    Last update posted :
    04/06/2022
    Initiation :
    05/02/2019
    Primary completion :
    12/31/2022
    Completion :
    12/31/2023
    ROS1
    |
    ROS1 rearrangement
    |
    Lorbrena (lorlatinib)
    A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy (NCT05287386)
    Phase 2
    The First Affiliated Hospital of Xiamen University
    Recruiting
    Last update posted :
    03/18/2022
    Initiation :
    01/21/2022
    Primary completion :
    01/21/2024
    Completion :
    01/21/2025
    EGFR • ALK
    |
    EGFR mutation • ALK positive • ALK rearrangement • ROS1 rearrangement
    |
    Pemazyre (pemigatinib)
    Evaluating Crizotinib in the Neoadjuvant Setting in Patients With Non-small Cell Lung Cancer (NCT03088930)
    Phase 2
    University of Colorado, Denver
    Completed
    Last update posted :
    02/11/2022
    Initiation :
    12/13/2017
    Primary completion :
    01/13/2021
    Completion :
    01/13/2021
    ALK • MET • ROS1
    |
    ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • MET mutation • MET fusion
    |
    Xalkori (crizotinib)