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A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

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Trial Profile

A Randomized, Open-Label, Multicenter Phase 3 Study to Evaluate SKB264 Monotherapy Versus Pemetrexed in Combination With Platinum in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OptiTROP-Lung04

Most Recent Events

  • 31 Oct 2024 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, the Application is the third NDA for sac-TMT that has been accepted by the NMPA. On October 25, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE.
  • 31 Oct 2024 Interim results presented in a Sichuan Kelun-Biotech Biopharmaceutical media release, at a pre-specified interim analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared with pemetrexed plus platinum chemotherapy. Sac-TMT also showed a manageable safety profile, with no unexpected safety signals identified.
  • 31 Oct 2024 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, the new drug application (NDA), based on the positive results from this pivotal phase 3 OptiTROP-Lung04 study was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in adult patients with EGFR-mutant locally advanced or metastatic non-small cell lung cancer who progressed after treatment with EGFR-tyrosine kinase inhibitor therapy.

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