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A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

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

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Trial sites expanded: 1 → 81 locations · Secondary endpoints: 6 to 12v5 Show 2 more changesShow less
    • Trial sites expanded: 1 → 81 locations
    • Secondary endpoints: 6 to 12

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria revisedv4 See this version in full on ClinicalTrials.gov ↗
  3. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.v3
  4. Start date: Oct 19, 2024 to Oct 30, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.
Trial Details
NCT Number NCT06711900
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Non-Small Cell Lung Cancer
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov