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Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion date: Dec 2025 to Dec 2026v19
  2. Notable Results first posted: Dec 3, 2025v18
  3. Minor Eligibility criteria revised Secondary endpoints: 15 to 16v17 Show 1 more changeShow less
  4. Notable Primary endpoints revised (2) Secondary endpoints: 14 to 15v16 Show 1 more changeShow less
  5. Minor Completion date: Jul 2025 to Dec 2025 Secondary endpoints: 7 to 14 · Primary endpoints revised (2)v15 Show 2 more changesShow less
    • Secondary endpoints: 7 to 14
    • Primary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

Show 13 earlier versionsHide 13 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv14
  2. Minor Primary completion date changed from estimate of Jul 2024 to Jul 29, 2024v13
  3. Notable Primary completion date: Oct 2023 to Jul 2024 Primary endpoints revised (2) · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 336 to confirmed 315 · 8 morev12 Show 11 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 336 to confirmed 315
    • Study sites: 63 to 124
    • Completion date: Jul 2024 to Jul 2025
    • Interventions: DZD9008 (Drug) to Sunvozertinib (Drug)
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 1 to 7
    • Study description revised
    • Study title revised
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Site contacts updated at 1 of 63 sitesv11
  5. Notable Primary completion date: Dec 2022 to Oct 2023 Completion date: Mar 2023 to Jul 2024v10 Show 1 more changeShow less
    • Completion date: Mar 2023 to Jul 2024
  6. Minor Study sites: 44 to 63v9
  7. Minor Study sites: 18 to 44 Eligibility criteria expanded, about 79 words · Study arms: 1 to 8v8 Show 2 more changesShow less
    • Eligibility criteria expanded, about 79 words
    • Study arms: 1 to 8

    See this version in full on ClinicalTrials.gov ↗

  8. Notable Enrollment target: 220 to 336v7
  9. Minor Enrollment target: 160 to 220 Study description expanded, about 4 wordsv6 Show 1 more changeShow less
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Study sites: 1 to 18v5
  11. Notable Lead sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. to Dizal Pharmaceuticalsv4
  12. Minor Re-verified, no change to tracked fieldsv3
  13. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 2019 to Jul 9, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2019 to Jul 9, 2019
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Trial Details
NCT Number NCT03974022
Lead Sponsor Dizal Pharmaceuticals
Conditions Non-Small Cell Lung Cancer
Enrollment 315 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov