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    GENE:

    ALK (Anaplastic lymphoma kinase)

    i
    Other names: NBLST3, CD246, Anaplastic Lymphoma Kinase, Anaplastic Lymphoma Kinase (Ki-1), CD246 Antigen, Mutant Anaplastic Lymphoma Kinase, ALK, ALK Receptor Tyrosine Kinase, Anaplastic Lymphoma Receptor Tyrosine Kinase, ALK Tyrosine Kinase Receptor
    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)
    1d
    CD45BE-HSPC + CART-45 Cells (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, University of Pennsylvania
    New P1 trial
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    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • CD8 (cluster of differentiation 8) • BCL6 (B-cell CLL/lymphoma 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    1d
    A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P2, N=41, Recruiting, Jennifer Crombie, MD | Active, not recruiting --> Recruiting
    Enrollment open
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    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
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    ALK positive • CD20 positive
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    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • prednisone • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
    1d
    An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE) (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, University Health Network, Toronto | Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Aug 2026
    Enrollment closed • Trial completion date
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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    EGFR wild-type • ALK wild-type
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    Avastin (bevacizumab) • Tecentriq (atezolizumab)
    2d
    Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy (clinicaltrials.gov)
    P2, N=13, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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    EGFR mutation • ALK mutation
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    Imfinzi (durvalumab)
    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
    Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Feb 2026 --> Feb 2027
    Trial initiation date
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    ALK (Anaplastic lymphoma kinase) • CD5 (CD5 Molecule) • DUSP22 (Dual Specificity Phosphatase 22) • USP22 (Ubiquitin Specific Peptidase 22)
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    ALK negative
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    Rituxan (rituximab) • cyclophosphamide • fludarabine IV
    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
    ALK-Positive Histiocytosis of the Pediatric Subglottic Airway. (PubMed, Laryngoscope)
    We report the case of a 3-year-old boy with progressively worsening biphasic stridor, found to have an isolated ALK+ histiocytic lesion in the subglottis. This case represents the first reported instance of an isolated ALK+ histiocytic lesion of the airway managed with endoscopic debulking.
    Journal
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK rearrangement
    2d
    Driver gene mutations and clinical features predict bone metastasis risk in NSCLC: a logistic regression model. (PubMed, Cancer Genet)
    These findings suggest EGFR mutation is a key molecular driver of early bone metastasis in NSCLC. Integrating molecular markers with clinical features into an interpretable prediction model can improve personalized risk assessment for bone metastasis and facilitate timely intervention.
    Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
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    KRAS mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    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)