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Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor changed: Dizal (Jiangsu) Pharmaceutical Co., Ltd. to Dizal Pharmaceuticals Enrollment increased: 160 → 220 participants · Study sites: 17 to 16v5 Show 2 more changesShow less
    • Enrollment increased: 160 → 220 participants
    • Study sites: 17 to 16

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment reduced: 200 → 160 participants Trial sites expanded: 7 → 17 locationsv4 Show 1 more changeShow less
    • Trial sites expanded: 7 → 17 locations
  3. Study sites: 4 to 7 Primary completion date: Dec 2028 to Jun 2028 · Completion date: Dec 2029 to Dec 2028 · Start date: Jul 31, 2025 to Jul 30, 2025v3 Show 3 more changesShow less
    • Primary completion date: Dec 2028 to Jun 2028
    • Completion date: Dec 2029 to Dec 2028
    • Start date: Jul 31, 2025 to Jul 30, 2025
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Aug 2025 to Jul 31, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Aug 2025 to Jul 31, 2025
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment
Trial Details
NCT Number NCT07079475
Lead Sponsor Dizal Pharmaceuticals
Conditions Non-Small Cell Lung Cancer
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov