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Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC

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

Record History

  1. Primary completion date changed from estimate of Sep 20, 2024 to Apr 10, 2025 Start date: Jun 20, 2023 to Oct 31, 2023 · Trial status: Recruiting to Active, Not Recruiting · Site details revisedv3 Show 3 more changesShow less
    • Start date: Jun 20, 2023 to Oct 31, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  2. Primary endpoint revised Eligibility criteria revised · Secondary endpoints revised (7) · Study description expanded, about 14 wordsv2 Show 3 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (7)
    • Study description expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 III, open-label, single-arm, multicenter study designed to evaluate the anti-tumor activity and safety of SY-5007 administered orally to participants with locally advanced or metastatic RET-positive NSCLC.
Trial Details
NCT Number NCT06031558
Lead Sponsor Shouyao Holdings (Beijing) Co. LTD
Conditions Non-Small Cell Lung Cancer
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov