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    BIOMARKER:

    ROS1 rearrangement

    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
    Entrez ID:
    6098
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    3d
    IIIb confirmatory clinical study of boritinib in patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 mutation (ChiCTR2500115365)
    P3, N=131, Recruiting, Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement • EGFR wild-type • MET exon 14 mutation • ROS1 rearrangement • MET mutation
    3d
    An Open-Label, Single-Center, Multi-Cohort, Phase II Study Evaluating the Safety and Efficacy of Vebreltinib-Based Combination Therapy in Previously Treated Patients with Locally Advanced or Metastatic MET-Overexpressing Non-Small Cell Lung Cancer (ChiCTR2500112942)
    P2, N=52, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 trial
    |
    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)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • ALK rearrangement • MET exon 14 mutation • MET overexpression • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • MET mutation • MET expression • RET rearrangement • NTRK fusion
    |
    docetaxel • Jiataile (sacituzumab tirumotecan) • bozitinib (APL-101)
    3d
    A First-In-Human, Multicenter, Open-Label Phase I/II Investigational Study to Evaluate the Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of KY-0301 as monotherapy or combined with other anticancer agents in Patients with advanced Solid Tumors (ChiCTR2600116103)
    P1/2, N=120, Recruiting, Shanghai East Hospital; Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • KRAS mutation • EGFR mutation • MSI-H/dMMR • BRAF mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ALK rearrangement • EGFR wild-type • MET exon 14 mutation • KRAS wild-type • RAS wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • NTRK fusion
    11d
    Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=66, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Aug 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
    |
    BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • nintedanib
    18d
    Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. (PubMed, Eur J Cancer)
    Dirozalkib exhibited favorable safety, antitumor activity and pharmacokinetics in patients with advanced ALK-rearranged NSCLC. The recommended phase II dose was 500 mg/day.
    P1 data • Preclinical • Journal • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK rearrangement • ALK fusion • ROS1 rearrangement
    |
    Xuan Fei Ning (dirozalkib)
    23d
    Differential Prevalence and Prognostic Significance of Spread Through Air Spaces According to Oncogenic Driver Mutations in Lung Adenocarcinoma. (PubMed, J Thorac Cardiovasc Surg)
    The prevalence and prognostic significance of STAS varied by driver mutation status, suggesting that the clinical interpretation of STAS may depend on the molecular context.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • EGFR wild-type • ALK mutation • ROS1 rearrangement
    24d
    First Report of Entrectinib as a Treatment Option for Pure Squamous Cell Carcinoma Harboring ROS1 Rearrangement: Exploring the Role of Next-Generation Sequencing in Targeted Therapy. (PubMed, Int J Mol Sci)
    This case highlights the potential of ROS1 as a therapeutic target in SCC, which has historically been considered rare, as ROS1-rearranged SCC accounts for only 0.2% according to the Foundation Medicine database. This underscores the importance of incorporating NGS into clinical practice, particularly for never smokers/light smokers or patients with advanced SCC of the lungs, to identify targetable mutations and guide personalized therapy.
    Journal • Next-generation sequencing
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ROS1 rearrangement
    |
    Rozlytrek (entrectinib)
    25d
    STARTRK-2: 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) (clinicaltrials.gov)
    P2, N=534, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2025 --> May 2026
    Trial completion date • Trial primary completion date • Pan tumor
    |
    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)
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Rozlytrek (entrectinib)
    2ms
    Consensus on the Diagnosis and Treatment of Unresectable Stage III Driver Gene-Positive Non-Small Cell Lung Cancer. (PubMed, Cancer Lett)
    The landmark LAURA and POLESTAR studies have established a standard therapeutic model involving targeted consolidation therapy with osimertinib or aumolertinib after definitive chemoradiotherapy for NSCLC patients harboring EGFR-sensitive mutations. Through multiple rounds of comprehensive discussion and expert voting, this consensus was jointly developed. It provides evidence-based recommendations addressing frequently encountered clinical questions regarding unresectable stage III driver-positive NSCLC, aiming to serve as a key reference for clinical practice.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK rearrangement • ALK fusion • ROS1 fusion • ROS1 rearrangement
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib)
    2ms
    eVOLVE-Lung02: A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P3, N=1200, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement • PD-L1 negative • ROS1 rearrangement
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • volrustomig (MEDI5752)
    2ms
    Postoperative recurrence of ROS1-rearranged lung adenocarcinoma: A case series. (PubMed, Thorac Cardiovasc Surg)
    Crizotinib showed limited efficacy with a median progression-free survival of 3.5 months. These findings highlight indolent disease behavior but limited TKI benefit, supporting the need for adjuvant trials.
    Journal
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ROS1 positive • ROS1 rearrangement
    |
    Xalkori (crizotinib)