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A Phase II Study of SKB571 in Patients With Lung Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 190 → 295 participantsv5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Dec 13, 2027 to Jan 19, 2028 · Start date changed from estimate of Dec 13, 2025 to Jan 19, 2026 · Site details revised at 2 of 2 sitesv3 Show 3 more changesShow less
    • Primary and study completion dates: Dec 13, 2027 to Jan 19, 2028
    • Start date changed from estimate of Dec 13, 2025 to Jan 19, 2026
    • Site details revised at 2 of 2 sites
  4. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 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 NCT07230405
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Lung Cancer (Non-Small Cell)
Enrollment 295 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov