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A Study of SKB518 in Patients With Lung Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Trial status: Not Yet Recruiting to Recruiting · Enrollment target: 80 to 192 · Primary endpoints: 2 to 3 · 8 morev2 Show 11 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 80 to 192
    • Primary endpoints: 2 to 3
    • Study sites: 1 to 17
    • Primary completion date: Jun 20, 2027 to Feb 20, 2027
    • Completion date: Jun 20, 2027 to Oct 20, 2027
    • Start date changed from estimate of Jun 20, 2025 to Aug 29, 2025
    • Interventions: SKB518 for injection (Drug) to Carboplatin (Drug), SKB518 (Drug), Tislelizumab (Drug)
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 3 to 5
    • Study arms: 1 to 3

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Trial Details
NCT Number NCT07019675
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Lung Carcinoma
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov