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    DRUG:

    sutetinib (SZMD4)

    i
    Other names: SZMD4
    Company:
    Jiangsu Suzhong Pharma, Medolution, Teligene
    Drug class:
    EGFR inhibitor
    Related drugs:
    5ms
    Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=99, Recruiting, Teligene US | Phase classification: P2b --> P2
    Phase classification • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    sutetinib (SZMD4)
    7ms
    The effect of food on the pharmacokinetics of Sutetinib maleate capsule, an irreversible EGFR tyrosine kinase inhibitor, in healthy Chinese subjects. (PubMed, Invest New Drugs)
    The registration No. is CTR20201933, and the date of registration is 2020-10-16).
    PK/PD data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    sutetinib (SZMD4)
    9ms
    A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=66, Recruiting, Teligene US | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2025 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    sutetinib (SZMD4)
    11ms
    A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=66, Recruiting, Teligene US
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    sutetinib (SZMD4)
    1year
    A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=66, Recruiting, Teligene US | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    sutetinib (SZMD4)
    1year
    A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Teligene US
    New P2 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    sutetinib (SZMD4)
    over1year
    A phase 2a study evaluating the efficacy and safety of sutetinib in patients with advanced non–small-cell lung cancer (NSCLC) harboring uncommon EGFR mutations. (ASCO 2023)
    Sutetinib demonstrated a high response rate with durable antitumor activity in patients with NSCLC harboring uncommon EGFR mutations. The toxicities are expected and comparable to other EGFR TKIs. A multi-center phase 2b study is ongoing in the United States and China to further evaluate Sutetinib in uncommon EGFR mutation NSCLC.
    Clinical • P2a data • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    sutetinib (SZMD4)
    over1year
    Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2b, N=99, Recruiting, Teligene US | Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Aug 2024
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR G719X + EGFR S768I
    |
    sutetinib (SZMD4)