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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:
    2d
    A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov)
    P1/2, N=67, Recruiting, D3 Bio (Wuxi) Co., Ltd | Active, not recruiting --> Recruiting | Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Apr 2028 --> Aug 2028
    Enrollment open • Trial completion date • Trial primary completion date • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
    |
    BRAF V600E • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR T790M • KRAS G12D • ALK rearrangement • MET exon 14 mutation • EGFR L861Q • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • RET rearrangement • KRAS G12 • KRAS G12S • KRAS Q61
    |
    D3S-002 • elisrasib (D3S-001)
    8d
    ALINEAR: Trop2 NMR Concordance Study (clinicaltrials.gov)
    P=N/A, N=3400, Not yet recruiting, AstraZeneca
    New trial
    |
    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) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • EGFR L861Q • ROS1 rearrangement • EGFR G719X • EGFR S768I
    |
    VENTANA® TROP2 (EPR20043) RxDx Assay
    25d
    PD-L1 expression is associated with inferior outcomes independent of EGFR subtype in advanced non-small cell lung cancer with uncommon EGFR mutations treated with first-line second-generation EGFR-tyrosine kinase inhibitors. (PubMed, Cancer)
    In advanced NSCLC with uncommon EGFR mutations, first-line second-generation EGFR-TKI monotherapy shows no statistically significant efficacy differences across mutation subtypes. PD-L1 expression is inversely associated with outcomes, with prognostic value differing between primary tumors and metastatic lymph nodes, highlighting the importance of tissue sampling site in risk stratification.
    Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR mutation • PD-L1 overexpression • EGFR expression • EGFR L861Q • EGFR G719X • EGFR S768I • PD-L1 expression + EGFR mutation
    25d
    Pharmacogenetic landscape of epidermal growth factor receptor mutations in Kurdish non-small cell lung cancer patients: implications for precision oncology. (PubMed, Ecancermedicalscience)
    According to available data, rare G719X/S768I variants (2.0%) may benefit from Afatinib, but Exon 19 deletions were the most common subtype in clinical settings (70.4% of EGFR-positive cases), indicating the use of first-line Osimertinib. However, the study's retrospective design and small sample sizes for uncommon mutation subtypes are among its limitations, which call for additional prospective validation in larger cohorts. These findings highlight the need for specialised diagnostic and treatment approaches in underrepresented populations and advance our understanding of the heterogeneity of EGFR mutations across ethnic groups.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR G719X • EGFR S768I • EGFR positive
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib)
    1m
    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)
    1m
    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)
    2ms
    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)
    2ms
    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
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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