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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
    Targeted therapies in non-small cell lung cancer and their cardiovascular impact: mechanisms, clinical profiles, and strategies of management. (PubMed, Front Pharmacol)
    As targeted therapies continue to expand across disease stages and treatment lines, CV toxicity is expected to play an increasingly important role in therapeutic decision-making. Integrating CV considerations into oncologic care is therefore essential to preserve treatment continuity, optimize long-term outcomes, and maximize the benefits of modern targeted therapies in NSCLC.
    Review • Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    1d
    Clinical Concordance of Pan Lung Cancer PCR Panel Covering 167 Actionable Variants Across 11 Genes and Other Validated Assays in the LC-SCRUM-Asia Registry. (PubMed, JTO Clin Res Rep)
    The Pan Lung Cancer PCR Panel was highly concordant with other assays. The panel can be performed in local laboratories with a rapid turnaround time and represents an attractive alternative to next-generation sequencing for patients with lung cancer.
    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) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • RET fusion • MET exon 14 mutation • ALK fusion • ROS1 fusion • MET mutation • KRAS G12 • NTRK fusion
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    Oncomine™ Dx Target Test
    6d
    Eucalyptus: Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) (clinicaltrials.gov)
    P3, N=163, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting
    Enrollment closed
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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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    Keytruda (pembrolizumab)
    7d
    Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC (clinicaltrials.gov)
    P1, N=20, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Recruiting | N=13 --> 20 | Trial primary completion date: Dec 2025 --> Jun 2026
    Enrollment open • Enrollment change • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule)
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    Opdivo (nivolumab) • cyclophosphamide • fludarabine IV
    7d
    NCI-2019-03212: Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy (clinicaltrials.gov)
    P2, N=27, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD4 (CD4 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
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    BRAF V600E • EGFR mutation • BRAF V600 • ALK mutation • ROS1 positive
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    carboplatin • paclitaxel • pevonedistat (MLN4924)
    8d
    DIONE-01: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (clinicaltrials.gov)
    P1, N=210, Active, not recruiting, iOnctura | Trial completion date: Mar 2025 --> Mar 2027
    Trial completion date • First-in-human
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    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    BRAF mutation • BRAF V600 • ALK translocation
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    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
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    cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)
    8d
    Safety and Efficacy of Xalkori ROS1 (clinicaltrials.gov)
    P=N/A, N=97, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | Trial completion date: Mar 2027 --> Nov 2026 | Trial primary completion date: Mar 2027 --> Nov 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ROS1 positive
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    Xalkori (crizotinib)
    9d
    BT8009-202: Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer (2025-521115-40-00)
    P1/2, N=28, Active, not recruiting, Bicycletx Limited | Recruiting --> Active, not recruiting
    Enrollment closed
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
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    zelenectide pevedotin (BT8009)
    9d
    A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=38, Recruiting, Shanghai Henlius Biotech | N=22 --> 38
    Enrollment change
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    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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    PD-L1 expression • EGFR mutation • MET exon 14 mutation
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    HLX43
    10d
    Molecular Profiling across 80,000 Patients with Lung Cancer. (PubMed, J Thorac Oncol)
    This is the largest NSCLC dataset analyzed for biomarker distribution across histologies, age, sex and genetic ancestry. This dataset confirms sufficient enough biomarker prevalence across many histological subtypes of NSCLC, providing reassurance that all NSCLC cases should be considered for biomarker workup.
    Journal • Tumor mutational burden
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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) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS G12C • HER-2 amplification • MET amplification • ALK rearrangement • TMB-L • ROS1 rearrangement • RET rearrangement • KRAS G12
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    FoundationOne® CDx
    10d
    Case report: successful use of repotrectinib in a ROS1 fusion-positive lung adenocarcinoma patient with severe renal insufficiency and prior tyrosine kinase inhibitor treatment failure. (PubMed, Anticancer Drugs)
    The patient received treatment with crizotinib and entrectinib successively. No new severe drug-related adverse events were observed. This case suggests that in patients with ROS1 fusion-positive nonsmall cell lung cancer who have experienced prior ROS1-tyrosine kinase inhibitor treatment failure and concomitant severe renal insufficiency, repotrectinib may represent a potential and tolerable treatment option when fully assessing clinical risks and ensuring close monitoring.
    Journal
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    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • SDC4 (Syndecan 4)
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    ROS1 fusion • ROS1 positive
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    Xalkori (crizotinib) • Rozlytrek (entrectinib) • Augtyro (repotrectinib)