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A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

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Trial Profile

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 May 2025

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At a glance

  • Drugs Lurbinectedin (Primary)
  • Indications Advanced breast cancer; Biliary cancer; Carcinoma; Endometrial cancer; Ewing's sarcoma; Germ cell and embryonal neoplasms; Germ cell cancer; Head and neck cancer; Male breast cancer; Neuroendocrine tumours; Salivary gland cancer; Small cell lung cancer; Solid tumours
  • Focus Registrational; Therapeutic Use
  • Acronyms study B-005
  • Sponsors PharmaMar

Most Recent Events

  • 19 May 2025 According to a PharmaMar media release, based on data from this trial the company received the conditional marketing approval for Zepzelca (lurbinectedin) from Argentinas National Administration of Drugs, Foods and Medical Devices (ANMAT) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
  • 01 Feb 2024 Results of post-hoc analysis of two studies NCT02454972 and NCT02566993, published in the Lung Cancer.
  • 12 Dec 2023 According to a PharmaMar media release, based on the data of 105 adult patients with relapsed SCLC from this study, the Luye Pharma as received marketing approval for Zepzelca (lurbinectedin) by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.

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