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    BIOMARKER:

    EGFR S768I

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor
    Entrez ID:
    1956
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    14h
    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)
    14d
    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
    25d
    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)
    28d
    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)
    1m
    EAY131-A: Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR L861Q • EGFR S768I
    |
    Gilotrif (afatinib)
    1m
    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)
    1m
    D516KC00001: A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib (2024-511362-37-00)
    P2/3, N=200, Recruiting, AstraZeneca AB | Active, not recruiting --> Recruiting
    Enrollment open
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • Datroway (datopotamab deruxtecan-dlnk)
    2ms
    TAS6417-302: Study Evaluating Zipalertinib with Chemotherapy for Lung Cancer Patients with Uncommon EGFR Mutations After Surgery (2025-521775-31-00)
    P2/3, N=131, Recruiting, Taiho Oncology Inc.
    New P2/3 trial
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR exon 20 mutation
    |
    cisplatin • carboplatin • pemetrexed • zipalertinib (CLN-081)
    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=324, Recruiting, Taiho Oncology, Inc. | N=224 --> 324 | Trial completion date: Aug 2026 --> Dec 2028 | Trial primary completion date: Feb 2026 --> Aug 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    zipalertinib (CLN-081)
    2ms
    Case Report: A patient harboring rare EGFR S768I/V769L compound mutation benefited from afatinib and osimertinib. (PubMed, Front Pharmacol)
    After multi-disciplinary treatment, the patient received concurrent chemoradiotherapy with pemetrexed and cisplatin, and achieved partial response. This patient did not receive durvalumab immunoconsolidation therapy for economic reasons...Patients with EGFR S768I/V769L compound mutated NSCLC may benefit from afatinib and osimertinib. Drugs with strong brain penetration capabilities are still needed for patients with S768I/V769L compound mutation to further improve survival outcomes.
    Journal • PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR S768I
    |
    cisplatin • Tagrisso (osimertinib) • Gilotrif (afatinib) • Imfinzi (durvalumab) • pemetrexed • simmitinib (SYHA1817)
    2ms
    Favorable response to third-generation TKI furmonertinib in a patient with early-stage non-small cell lung cancer​ harboring rare compound EGFR mutations: Exon 18 G719C and Exon 20 S768I - A Case Report. (PubMed, Front Oncol)
    Here, we describe a case of early-stage non-small cell lung cancer (NSCLC) harboring a G719C+S768I compound mutation that achieved complete remission following treatment with furmonertinib. These findings suggest that furmonertinib may represent a promising therapeutic option to improve cure rates in this subset of patients.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR S768I
    |
    Ivesa (firmonertinib)
    2ms
    Adjuvant icotinib and osimertinib in the treatment of EGFR-mutated resectable non-small cell lung cancer: A real-world multicenter cohort study in China (ChiCTR2500112843)
    P=N/A, N=200, Not yet recruiting, Beijing Chest Hospital Capital Medical University; Beijing Chest Hospital Capital Medical University
    New trial
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
    |
    TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Tagrisso (osimertinib) • Conmana (icotinib) • simmitinib (SYHA1817)