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A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Profile

A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2026

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary) ; Pembrolizumab
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OptiTROP-Lung05
  • Sponsors Sichuan Kelun Pharmaceutical Research Institute

Most Recent Events

  • 24 Nov 2025 According to the Sichuan Kelun Biotech Biopharmaceutical media release, Based on the results from the interim analysis, the Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China regarding the submission of a supplemental new drug application (sNDA) of sac-TMT.
  • 24 Nov 2025 Interim results published in the Sichuan Kelun Biotech Biopharmaceutical Media Release.
  • 12 Jun 2024 New trial record

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