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    GENE:

    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

    i
    Other names: ROS1, ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, V-Ros Avian UR2 Sarcoma Virus Oncogene Homolog 1, C-Ros Oncogene 1 Receptor Tyrosine Kinase, Proto-Oncogene Tyrosine-Protein Kinase ROS, Proto-Oncogene C-Ros-1, MCF3, ROS, V-Ros UR2 Sarcoma Virus Oncogene Homolog 1 (Avian), ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, Transmembrane Tyrosine-Specific Protein Kinase, Receptor Tyrosine Kinase C-Ros Oncogene 1, C-Ros Receptor Tyrosine Kinase, Proto-oncogene C-Ros, C-Ros-1
    1d
    U31402-A-U102: U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=312, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • KRAS G12
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    patritumab deruxtecan (U3-1402)
    2d
    Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027
    Trial completion date • Tumor mutational burden • IO biomarker
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSH6 (MutS homolog 6)
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
    2d
    A Single-Arm, Open-Label, Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors (clinicaltrials.gov)
    P2, N=56, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • EGFR mutation • BRAF V600 • ALK positive • RET fusion • ALK fusion • ALK mutation • RET mutation • ROS1 fusion • EGFR positive • NTRK fusion
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    Avastin (bevacizumab) • etoposide IV • utidelone IV (UTD1)
    2d
    Analysis of Acquired Fusion Mutations in EGFR-TKIs-Resistant Patients with Advanced Lung Cancer. (PubMed, J Coll Physicians Surg Pak)
    One patient with acquired fusion gene mutations developed small-cell lung cancer transformation after ALK-TKIs resistance. Key Words: Lung cancer, ALK fusion, RET fusion, ROS1 fusion, EGFR-TKIs-resistance, Targeted therapy.
    Journal
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    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation • RET fusion • ALK fusion • RET mutation • ROS1 fusion
    2d
    TROPION-Lung17: Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations (clinicaltrials.gov)
    P3, N=82, Recruiting, AstraZeneca
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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    KRAS G12C • MET exon 14 mutation • KRAS G12
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    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    3d
    Izalontamab Brengitecan in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations Outside of Classical EGFR Mutations: A Phase Ib Study. (PubMed, J Clin Oncol)
    iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical EGFR mutations, especially in EGFR exon20ins/nonclassical and HER2 mutations.
    P1 data • Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS mutation • EGFR mutation • BRAF mutation • RET fusion • EGFR exon 20 insertion • RET mutation • ROS1 fusion • MET mutation • EGFR exon 20 mutation • NTRK fusion
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    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    3d
    Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative (clinicaltrials.gov)
    P2/3, N=427, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2027 --> Dec 2030 | Trial primary completion date: Dec 2027 --> Dec 2030
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    PD-L1 expression • ALK mutation
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • paclitaxel • ABP 206 (nivolumab biosimilar)
    4d
    Stage IIIB ROS1-Positive NSCLC management: crizotinib + surgery + TCM achieves exceptionally prolonged PFS (a case report). (PubMed, Front Pharmacol)
    The last follow-up in August 2025 showed the patient remained in good survival status. This case highlights a novel strategy of neoadjuvant targeted downstaging followed by surgical resection for small-lesion, highly invasive NSCLC, as well as the potential value of integrating postoperative Chinese-Western medicine management for long-term survival and treatment tolerance.
    Journal
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ROS1 fusion • ROS1 positive
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    Xalkori (crizotinib)
    5d
    D763QC00001: A trial to learn how effective and safe datopotamab deruxtecan (Dato-DXd) is compared to docetaxel and how well Dato-DXd works in adults with advanced or metastatic TROP2-positive, non-squamous non-small cell lung cancer (NS-NSCLC). (2024-520101-39-00)
    P2/3, N=13, Not yet recruiting, AstraZeneca AB
    New P2/3 trial
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS G12C • MET exon 14 mutation • KRAS G12
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    docetaxel • Datroway (datopotamab deruxtecan-dlnk)
    6d
    Diagnostic Utility of Expression Imbalance in Idylla GeneFusion Assay for Non-Small Cell Lung Cancer. (PubMed, J Mol Diagn)
    One case showed an NOL10::ALK out-of-frame fusion with negative ALK immunohistochemistry and equivocal ALK FISH results. Because the expression imbalance method can detect novel fusions, we recommend its implementation with confirmation testing.
    Journal
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    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • STRN (Striatin) • SQSTM1 (Sequestosome 1) • ERC1 (ELKS/RAB6-Interacting/CAST Family Member 1)
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    RET fusion • ALK fusion • ROS1 fusion • ALK negative
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    Idylla™ GeneFusion Assay
    6d
    Deep Learning-Enhanced Biomarker Interpretation on Cytology Cell Blocks - Foundations and Emerging Opportunities in Spatial Pathobiology. (PubMed, Am J Pathol)
    Finally, we discuss the spatial pathobiology opportunities afforded by cell block preparations and outline future directions for integrating AI-enabled analysis into cytology workflows. Together, these advances position cytology cell blocks as an important platform for computational biomarker interpretation and morphology-driven precision oncology.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    BRAF V600E • BRAF V600
    7d
    A Study of TAK-505 in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=151, Not yet recruiting, Takeda
    New P1/2 trial • First-in-human
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    PD-L1 expression • MSI-H/dMMR • BRAF V600 • MET exon 14 mutation • RAS wild-type • EGFR positive