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    BIOMARKER:

    EGFR exon 20 mutation

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor
    Entrez ID:
    1956
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    1d
    Preclinical to clinical translation of pharmacokinetic-pharmacodynamic relationship in EGFR Exon20Ins mutations: a modelling framework for irreversible inhibitors. (PubMed, Mol Cancer Ther)
    We also explored clinical phosEGFR reduction induced by the 3rd generation TKI osimertinib, suggesting that limited target engagement may explain modest response achieved in EGFR Exon20Ins at the clinically investigated doses. The developed model is a valuable tool to understand the impact of kinetic characteristics on phosEGFR reduction and related efficacy, select a target engagement-based criterion for therapeutic dose predictions, and provide interpretation and insights on observed clinical efficacy of irreversible inhibitors in EGFR Exon20Ins.
    PK/PD data • Preclinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • simmitinib (SYHA1817)
    3d
    An open-label, multicenter, phase Ib/II clinical study to evaluate the safety, efficacy and pharmacokinetic characteristics of PLB1004 capsules in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive non-small cell lung cancer. (ChiCTR2500105771)
    P1/2, N=108, Recruiting, Shanghai Chest Hospital; Avistone Pharmaceutical(Ningbo)Co., LTD. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    andamertinib (PLB1004)
    5d
    Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov)
    P1/2, N=315, Active, not recruiting, Dizal Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Zegfrovy (sunvozertinib)
    7d
    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
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    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)
    7d
    Inverted Sinonasal Papilloma: Pheno-endotyping and Predictive Markers of Recurrence and Malignancy - A Systematic Review. (PubMed, Curr Allergy Asthma Rep)
    SNIP exhibits multifactorial biological behavior driven by inflammation, viral infection, and molecular dysregulation. These findings highlight the need for standardized histopathological and molecular criteria and prospective studies to refine recurrence prediction and early detection of malignant transformation.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
    |
    TP53 mutation • EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    8d
    Prolonged survival in EGFR exon 20 insertion mutant lung adenocarcinoma: case report of sequential osimertinib and furmonertinib with research trend analysis. (PubMed, Front Med (Lausanne))
    This analysis demonstrated a growing global research focus on third-generation EGFR-TKIs and variant-specific treatment strategies for EGFR ex20ins-mutant NSCLC, supporting the rationale underpinning the therapeutic approach adopted in this report. Sequential high-dose third-generation EGFR-TKIs may offer clinically meaningful benefit in selected EGFR ex20ins cases; however, this strategy remains non-standard and should be regarded as hypothesis-generating, warranting further prospective evaluation.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • ETV6 (ETS Variant Transcription Factor 6) • SMAD4 (SMAD family member 4) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase)
    |
    PD-L1 expression • TP53 mutation • EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Ivesa (firmonertinib) • simmitinib (SYHA1817)
    10d
    Furmonertinib in lung adenocarcinoma with EGFR exon 20 insertion mutation: A case report of positive outcome. (PubMed, Medicine (Baltimore))
    Furmonertinib, as a third-generation EGFR-TKI, demonstrated substantial efficacy in patients with advanced EGFR20ins-mutant NSCLC, significantly extending PFS and improving quality of life. This drug offers a promising new treatment option for patients with resistance to conventional therapies. Further studies will help validate the application of furmonertinib in a broader patient population.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Ivesa (firmonertinib)
    18d
    Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)
    25d
    First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations (clinicaltrials.gov)
    P1/2, N=251, Recruiting, Pierre Fabre Medicament | N=185 --> 251 | Trial completion date: Jun 2028 --> Dec 2029 | Trial primary completion date: Jun 2027 --> Dec 2029
    Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
    |
    STX-721
    27d
    Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • MET overexpression • EGFR exon 20 mutation
    |
    CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody • VENTANA® MET (SP44) RxDx Assay
    |
    Tagrisso (osimertinib) • Emrelis (telisotuzumab vedotin-tllv) • simmitinib (SYHA1817)
    29d
    Efficacy and safety of later-line targeted therapies in advanced non-small cell lung cancer with EGFR exon 20 insertion mutations: a systematic review. (PubMed, Front Pharmacol)
    Recent developments in targeted therapies, including agents such as amivantamab, mobocertinib, and sunvozertinib, have shown promise in patients with pretreated ex20ins-positive NSCLC. No amendments were made to the registered protocol after commencement of the review. The full review protocol can be accessed on the PROSPERO database (Registration number: CRD420251056825).
    Review • Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Exkivity (mobocertinib) • Zegfrovy (sunvozertinib)
    1m
    CHRYSALIS-2: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=701, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2026 --> Mar 2028
    Trial completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR expression • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib)