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    BIOMARKER:

    ALK mutation

    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
    Entrez ID:
    238
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    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
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
    |
    BRAF V600 • ALK fusion • ALK mutation
    |
    Ensacove (ensartinib)
    2d
    The Correlation Among PD-L1 Expression and the Driver Genes Status in Malignant Pleural Effusion of Lung Adenocarcinoma. (PubMed, Cytopathology)
    Our findings suggest that PD-L1 immunohistochemistry is effective for evaluating pleural fluid cytological specimens and that PD-L1 expression is significantly higher in lung adenocarcinoma patients with malignant pleural effusions associated with the KRAS, ALK and BRAF mutations.
    Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • 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) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • KRAS mutation • EGFR mutation • BRAF mutation • PIK3CA mutation • ALK mutation • MET mutation
    |
    VENTANA PD-L1 (SP263) Assay
    5d
    Immunotherapeutic advances in pediatric neuroblastoma: Overcoming resistance through biomarker-guided combinations. (PubMed, Biomed Pharmacother)
    Recent advances in immunotherapy have reshaped the treatment landscape, with anti-GD2 monoclonal antibodies such as dinutuximab and naxitamab demonstrating significant clinical benefit, especially when combined with granulocyte-macrophage colony-stimulating factor (GM-CSF)...This review synthesizes current evidence on immunotherapeutic strategies in neuroblastoma, highlighting resistance pathways, biomarker-driven approaches, and the evolving clinical trial landscape. Future directions emphasize personalized, biomarker-guided immunotherapy to improve efficacy, reduce toxicity, and establish durable, curative outcomes for children with neuroblastoma.
    Review • Journal • IO biomarker
    |
    ALK (Anaplastic lymphoma kinase) • CD276 (CD276 Molecule) • CSF2 (Colony stimulating factor 2) • L1CAM (L1 cell adhesion molecule)
    |
    ALK mutation
    |
    Unituxin (dinutuximab)
    6d
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=1021, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    7d
    Clinical study and mechanism of spleen-strengthening traditional Chinese medicine WD-3 combined with immunotherapy for lung cancer based on the theory of "Pei Tu Shengjin" (ChiCTR2500115477)
    P=N/A, N=220, Recruiting, Wuxi Hospital of Traditional Chinese Medicine; Wuxi Hospital of Traditional Chinese Medicine
    New trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK mutation • MET mutation
    7d
    Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR2500115167)
    P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P4 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR L858R • EGFR T790M • ALK mutation
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Ensacove (ensartinib) • Ameile (aumolertinib) • AiRuiLi (adebrelimab)
    7d
    A single-arm, multicenter clinical study of ensartinib combined with chemotherapy as neoadjuvant therapy for ALK-positive non-small cell lung cancer (NSCLC) (TD-ENSEMBLE study) (ChiCTR2500113689)
    P4, N=20, Not yet recruiting, The Second Affiliated Hospital of Air Force Medical University; The Second Affiliated Hospital of Air Force Medical University
    New P4 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK fusion • ALK mutation
    |
    Ensacove (ensartinib)
    7d
    A randomized controlled clinical study on postoperative adjuvant targeted therapy and MRD observation for stage IA non-small cell lung cancer (ChiCTR2500112620)
    P4, N=178, Not yet recruiting, Beijing chest hospital capital medical university; Beijing Chest Hospital Capital Medical University
    New P4 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK positive • ALK fusion • ALK mutation • EGFR positive
    |
    Conmana (icotinib) • Ensacove (ensartinib)
    7d
    SHR-A1811 plus QL1706 versus standard therapy as first-line treatment for locally advanced or metastatic HER2-overexpressing non-small cell lung cancer: an open-label, single-arm, phase II clinical trial (ChiCTR2500114106)
    P2, N=39, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • EGFR mutation • HER-2 overexpression • HER-2 mutation • ALK mutation • HER-2 positive + HER-2 overexpression
    |
    trastuzumab rezetecan (SHR-A1811) • Qibeian (iparomlimab/tuvonralimab)
    7d
    Stereotactic body radiotherapy with sequential Iparomlimab and tuvonralimab (QL1706) + chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (LUNG-Nanjing01): a single-arm, single-centre, phase 2 trial (ChiCTR2500112445)
    P2, N=29, Not yet recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • ALK mutation
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Qibeian (iparomlimab/tuvonralimab)
    7d
    Single-arm, open-label, prospective clinical study of the YMN-V138 vaccine for advanced non-small cell lung cancer (ChiCTR2600116270)
    P1, N=10, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CRIPTO (Cripto)
    |
    ALK mutation • EGFR negative
    8d
    ARC-27: A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=91, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • ALK mutation • MET mutation
    |
    docetaxel