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A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 Mutation

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Trial Profile

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 Mutation

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Jan 2025

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At a glance

  • Drugs Sunvozertinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms WU-KONG1; WU-KONG1B
  • Sponsors Dizal Pharmaceutical

    • Most Recent Events

    • 07 Jan 2025 According to a Dizal Pharmaceutical media release, the company announced that the U.S. FDA has accepted and granted priority review to the company's NDA for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
    • 01 Jan 2025 Pooled analysis results from this and WU-Kong15 studies assessing the efficacy and safety of sunvozertinib monotherapy in treating EGFR TKI-resistant patients with NSCLC harboring EGFR mutations were published in the Lung Cancer
    • 08 Nov 2024 According to a Dizal Pharmaceutical media release, the company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sunvozertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients. Submission is supported by results of part B of this study.

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