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    BIOMARKER:

    EGFR G719X

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor
    Entrez ID:
    1956
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    10d
    NEOVADE: Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC (clinicaltrials.gov)
    P2, N=32, Active, not recruiting, Guangdong Provincial People's Hospital | Trial completion date: Sep 2027 --> Apr 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    carboplatin • albumin-bound paclitaxel • Ameile (aumolertinib) • AiRuiLi (adebrelimab)
    12d
    Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=99, Recruiting, Teligene US | Trial completion date: Jun 2026 --> Dec 2028 | Trial primary completion date: Jun 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    sutetinib (SZMD4)
    17d
    REZILIENT4: A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (clinicaltrials.gov)
    P3, N=360, Active, not recruiting, Taiho Oncology, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR L861Q • EGFR G719X • EGFR S768I
    |
    cisplatin • carboplatin • pemetrexed • zipalertinib (CLN-081)
    19d
    ML41701: A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors. (clinicaltrials.gov)
    P2, N=22, Completed, National Taiwan University Hospital | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Feb 2026 | Trial primary completion date: Dec 2024 --> Feb 2026
    Trial completion • Trial completion date • Trial primary completion date • IO biomarker
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • pemetrexed
    28d
    Epidermal Growth Factor Receptor (EGFR) atypical mutations in Non-Small-Cell Lung Cancer (NSCLC): 'where the streets have no name'. (PubMed, Crit Rev Oncol Hematol)
    To date, afatinib remains the only approved agent specifically indicated for tumors harboring selected atypical variants-namely S768I, L861Q, and G719X-based on regulatory approvals by the FDA and EMA in 2018...Specifically, we will examine the efficacy of first-, second-, and third-generation EGFR TKIs in this subgroup, discuss the mechanisms underlying resistance, and highlight the clinical implications of the recently proposed structure-function-based classification of EGFR mutations. Finally, we will review emerging evidence from ongoing clinical trials of novel therapeutic agents, including bispecific antibodies and next-generation inhibitors, which may offer new opportunities for patients with atypical EGFR-mutant NSCLC.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib)
    1m
    Combining Furmonertinib With Local Therapy for Inoperable Early-stage Lung Cancer: A Phase II Trial (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Ivesa (firmonertinib)
    1m
    REZILIENT4: A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection (clinicaltrials.gov)
    P3, N=360, Recruiting, Taiho Oncology, Inc. | N=141 --> 360
    Enrollment change • Trial initiation date
    |
    EGFR L861Q • EGFR G719X • EGFR S768I
    |
    cisplatin • carboplatin • pemetrexed • zipalertinib (CLN-081)
    2ms
    Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC (clinicaltrials.gov)
    P2, N=23, Recruiting, Taipei Veterans General Hospital, Taiwan | Not yet recruiting --> Recruiting | Trial completion date: Jun 2027 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Tagrisso (osimertinib) • pemetrexed
    2ms
    FURTHER: Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations (clinicaltrials.gov)
    P1, N=160, Active, not recruiting, ArriVent BioPharma, Inc. | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 exon 20 insertion • EGFR G719X • EGFR S768I
    |
    Ivesa (firmonertinib)
    2ms
    REZILIENT2: A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. (clinicaltrials.gov)
    P2, N=220, Recruiting, Taiho Oncology, Inc. | N=324 --> 220
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    zipalertinib (CLN-081)
    2ms
    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
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • KRAS G12
    |
    patritumab deruxtecan (U3-1402)
    2ms
    Survival analysis and prognostic factors in advanced NSCLC harboring EGFR PACC mutations: A multicenter retrospective study. (PubMed, Lung Cancer)
    The G719X subtype was predominant, and compound mutations were frequently observed in patients with EGFR PACC-mutant NSCLC. The combination of chemotherapy and TKIs was associated with significant OS benefits, warranting future prospective clinical studies for confirmation.
    Retrospective data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR G719X • EGFR S768I
    |
    Ivesa (firmonertinib)