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    TEST:
    Guardant360® CDx

    Company:
    Guardant Health
    Related tests:
    3d
    Limited reliability of H3K27M detection using a commercially available blood-based comprehensive genomic profiling test in patients with diffuse midline gliomas: analysis of the nationwide C-CAT database in Japan. (PubMed, Int J Clin Oncol)
    Our findings indicate a critical limitation of F1 Liquid in detecting the H3K27M and other significant mutations in diffuse midline glioma.
    Journal
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    TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
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    IDH wild-type
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System
    11d
    Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. (clinicaltrials.gov)
    P1/2, N=40, Active, not recruiting, Criterium, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Aug 2024 --> Mar 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CD4 (CD4 Molecule)
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    HER-2 positive • PIK3CA mutation
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    Guardant360® CDx • FoundationOne® Liquid CDx • therascreen® PIK3CA RGQ PCR Kit
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    Piqray (alpelisib) • fulvestrant • Tukysa (tucatinib)
    15d
    ADELA: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (clinicaltrials.gov)
    P3, N=240, Recruiting, MedSIR | Active, not recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 mutation • ESR1 mutation
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
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    everolimus • dexamethasone • Orserdu (elacestrant)
    1m
    NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov)
    P2, N=93, Terminated, M.D. Anderson Cancer Center | Trial completion date: Dec 2027 --> Feb 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2027 --> Feb 2026; <75% participation
    Trial completion date • Trial termination • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
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    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
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    FoundationOne® CDx • Guardant360® CDx • cobas® EGFR Mutation Test v2 • therascreen® EGFR RGQ PCR Kit
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    Pozenveo (poziotinib)
    1m
    Prediction model for ctDNA detectability in liquid comprehensive genomic profiling of advanced pancreatic cancer based on Japanese real-world data. (PubMed, ESMO Open)
    This prediction model enables accurate pre-test estimation of ctDNA detectability in advanced pancreatic cancer and may enhance the clinical utility of liquid CGP by informing optimal test selection and timing.
    Journal • Real-world evidence • Circulating tumor DNA
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx
    2ms
    WJOG18524G: a single-arm phase II study evaluating bemarituzumab combined with ramucirumab and paclitaxel in fibroblast growth factor receptor 2b (FGFR2b)-positive advanced gastric or gastroesophageal junction cancer (RAINBIRD). (PubMed, ESMO Gastrointest Oncol)
    The primary endpoint is the objective response rate, which is assessed by a blinded independent central review. Translational research is planned to explore the predictive biomarkers and mechanisms of resistance to bemarituzumab by sequencing tumor DNA (PleSSiSion-Neo) and circulating tumor DNA (Guardant360), which are collected at multiple time points.
    P2 data • Journal
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    FGFR2 (Fibroblast growth factor receptor 2)
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    FGFR2 overexpression
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    Guardant360® CDx
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    paclitaxel • Cyramza (ramucirumab) • bemarituzumab (AMG 552)
    2ms
    NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 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)
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    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
    |
    FoundationOne® CDx • Guardant360® CDx • cobas® EGFR Mutation Test v2 • therascreen® EGFR RGQ PCR Kit
    |
    Pozenveo (poziotinib)
    2ms
    Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment (clinicaltrials.gov)
    P1/2, N=16, Active, not recruiting, National Cancer Institute (NCI) | N=58 --> 16 | Trial completion date: Nov 2025 --> Jan 2027
    Enrollment change • Trial completion date
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    BRAF V600E • BRAF V600 • BRAF V600K • EZH2 mutation
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    Guardant360® CDx
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    Mekinist (trametinib) • Tafinlar (dabrafenib) • Tazverik (tazemetostat)
    2ms
    G360-IIT: Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy (clinicaltrials.gov)
    P2, N=108, Recruiting, Hackensack Meridian Health | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Apr 2026 --> Apr 2027
    Trial completion date • Trial primary completion date • Circulating tumor DNA
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    PD-L1 IHC 22C3 pharmDx • Guardant360® CDx
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
    3ms
    BRICKET: Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Recruiting --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • MAP2K1 (Mitogen-activated protein kinase kinase 1)
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    BRAF V600E • MSI-H/dMMR • BRAF V600 • KRAS wild-type • NRAS wild-type
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    Guardant360® CDx
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    Erbitux (cetuximab) • Braftovi (encorafenib)
    3ms
    Clinical Feasibility of Circulating Tumor DNA in Patients with Advanced Hepatocellular Carcinoma Treated with Atezolizumab plus Bevacizumab. (PubMed, Liver Cancer)
    Additionally, ctDNA maxVAF demonstrated independent prognostic value in patients treated with first-line atezo/bev. Liquid biopsy using ctDNA can help address challenges associated with limited tissue-based genomic profiling in advanced HCC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
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    Guardant360® CDx
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    Avastin (bevacizumab) • Tecentriq (atezolizumab)
    4ms
    Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, National Cancer Institute (NCI) | N=85 --> 22 | Trial completion date: Jun 2026 --> Nov 2026 | Trial primary completion date: Jun 2026 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2)
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    BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • BRAF V600K • KEAP1 mutation • NFE2L2 mutation
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    Guardant360® CDx • MSK-IMPACT
    |
    sapanisertib (CB-228) • telaglenastat (CB-839)