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A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 160 to 158v9
  2. Primary completion date changed from estimate of Feb 28, 2026 to Jan 16, 2026 Study sites revised (160)v8 Show 1 more changeShow less
    • Study sites revised (160)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 320 to confirmed 324 · Site details revised at 160 of 160 sitesv7 Show 2 more changesShow less
    • Enrollment target: estimated 320 to confirmed 324
    • Site details revised at 160 of 160 sites
  4. Site details revised at 1 of 160 sitesv6
  5. Study sites: 133 to 160 Interventions: DZD9008 (Drug), Pemetrexed+carboplatin (Drug) to Pemetrexed+carboplatin (Drug), sunvozertinib (Drug)v5 Show 1 more changeShow less
    • Interventions: DZD9008 (Drug), Pemetrexed+carboplatin (Drug) to Pemetrexed+carboplatin (Drug), sunvozertinib (Drug)
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 41 to 133 Study title expanded, about 1 wordv4 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 31, 2023 to Dec 13, 2022 · Site details revised at 41 of 41 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 31, 2023 to Dec 13, 2022
    • Site details revised at 41 of 41 sites
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
Trial Details
NCT Number NCT05668988
Lead Sponsor Dizal Pharmaceuticals
Conditions Non-small Cell Lung Cancer
Enrollment 324 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov