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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
    Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial) (clinicaltrials.gov)
    P3, N=390, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2026 --> Feb 2027 | Trial primary completion date: Oct 2026 --> Dec 2025
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ALK rearrangement
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    erlotinib
    1d
    LIBRA: A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=278, Recruiting, AstraZeneca | Trial primary completion date: Mar 2027 --> Apr 2029
    Trial primary 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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    ALK rearrangement
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    Cyramza (ramucirumab) • Datroway (datopotamab deruxtecan-dlnk) • rilvegostomig (AZD2936)
    1d
    Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC (clinicaltrials.gov)
    P1, N=16, Terminated, Rutgers, The State University of New Jersey | Active, not recruiting --> Terminated; accrual goal met
    Trial termination
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LAG3 (Lymphocyte Activating 3) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD27 (CD27 Molecule)
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    BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement
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    Tecentriq (atezolizumab) • varlilumab (CDX 1127)
    1d
    Real-World Long-Term Outcomes of First-Line Pembrolizumab in Advanced PD-L1 ≥ 50% NSCLC: A Systematic Review and Meta-analysis. (PubMed, Ann Surg Oncol)
    Real-world evidence confirms the long-term effectiveness and safety of pembrolizumab monotherapy for advanced NSCLC with PD-L1 ≥50%. Survival outcomes closely mirrored those from previous trials, supporting the generalizability of pembrolizumab's benefit across routine practice.
    Retrospective data • Review • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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    PD-L1 expression
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    Keytruda (pembrolizumab)
    1d
    Clinicopathological and molecular features of acquired cystic disease-associated renal cell carcinoma (PubMed, Zhonghua Bing Li Xue Za Zhi)
    ACD-RCC is a rare renal cell carcinoma that occurs in patients with end-stage renal disease and has unique morphological features. It is often associated with favorable prognosis and alterations in genes related to the MTOR/TSC pathway or chromatin modification.
    Journal
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    ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • KMT2C (Lysine Methyltransferase 2C) • TSC2 (TSC complex subunit 2) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • TSC1 (TSC complex subunit 1) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • TFE3 (Transcription Factor Binding To IGHM Enhancer 3) • MME (Membrane Metalloendopeptidase) • KMT2B (Lysine Methyltransferase 2B) • GATA3 (GATA binding protein 3) • PAX8 (Paired box 8) • TFEB (Transcription Factor EB 2)
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    TP53 mutation
    1d
    Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov)
    P2, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
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    BRAF V600 • ALK fusion • ALK mutation
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    Ensacove (ensartinib)
    1d
    A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. (clinicaltrials.gov)
    P1/2, N=24, Not yet recruiting, University of Chicago
    New P1/2 trial
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    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTAG1B (Cancer/testis antigen 1B)
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    HER-2 positive • ER positive • EGFR mutation • BRAF mutation • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
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    cyclophosphamide • decitabine • Proleukin (aldesleukin)
    2d
    Epithelioid and spindle cell rhabdomyosarcoma of the rib with FUS-TFCP2 fusion: A case report and literature review. (PubMed, Oncol Lett)
    The patient succumbed to the disease 4 months after surgery. RMS with FUS-TFCP2 fusion is rare, highly aggressive and associated with a poor prognosis.
    Journal
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    ALK (Anaplastic lymphoma kinase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • FUS (FUS RNA Binding Protein) • TFCP2 (Transcription Factor CP2) • MYOD1 (Myogenic Differentiation 1)
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    CDKN2A deletion
    2d
    ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=31, Active, not recruiting, Washington University School of Medicine | N=114 --> 31 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation
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    gemcitabine • docetaxel • Hepacid (pegargiminase)
    2d
    A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | N=20 --> 30
    Enrollment change
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    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    Amtagvi (lifileucel) • LN-145
    2d
    CUBIK: Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients (clinicaltrials.gov)
    P2, N=33, Active, not recruiting, Fundación GECP | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial primary completion date • Liquid biopsy
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    ALK (Anaplastic lymphoma kinase)
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    ALK positive • ALK rearrangement
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    VENTANA ALK (D5F3) CDx Assay
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    Alunbrig (brigatinib)
    3d
    CURB: Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung (clinicaltrials.gov)
    P2, N=107, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    ALK rearrangement • ROS1 rearrangement