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    DRUG:

    Zepzelca (lurbinectedin)

    i
    Other names: PM1183, PM01183, PM 1183, PM-01183, LY01017, PM-1183, LY 01017, LY-01017, PM 01183
    Company:
    Boryung Group, EMD Serono, Jazz, Key Oncologics, Luye Group, PharmaMar, Specialised Therap
    Drug class:
    Alkylating agent, Apoptosis stimulant, RNA polymerase inhibitor
    Related drugs:
    2d
    LOTS: Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=16, Recruiting, Misty Shields | Not yet recruiting --> Recruiting | Initiation date: May 2026 --> Aug 2026
    Enrollment open • Trial initiation date
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • MET amplification
    |
    Tagrisso (osimertinib) • Zepzelca (lurbinectedin)
    4d
    An Exploratory Study of Lurbinectedin With Radiotherapy in SCLC With Single-lesion Progression After First Course Treatment (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Zepzelca (lurbinectedin)
    9d
    LUPINE: Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=69, Not yet recruiting, Yonsei University
    New P2 trial
    |
    paclitaxel • Zepzelca (lurbinectedin)
    13d
    PM1183-C-010-22: Public Title: Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Participants with Metastatic Leiomyosarcoma (2022-502975-45-00)
    P2/3, N=345, Active, not recruiting, Pharma Mar S.A. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    doxorubicin hydrochloride • dexamethasone • Zepzelca (lurbinectedin) • Neupogen (filgrastim) • ondansetron
    16d
    Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=550, Not yet recruiting, SystImmune Inc.
    New P3 trial
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Zepzelca (lurbinectedin)
    18d
    Updates in Small Cell Lung Cancer Treatment: No Longer Too Small to Ignore-A Review of Recent Therapeutic Advances. (PubMed, Am Soc Clin Oncol Educ Book)
    From approval of immune checkpoint inhibitors and lurbinectedin, a newer chemotherapy agent, to novel immunotherapies such as tarlatamab, a DLL3-CD3 bispecific T-cell engager, and other upcoming promising drugs, the therapeutic armamentarium for SCLC is steadily expanding. In this study, we review the current landscape of both systemic therapy as well as radiation therapy for SCLC, with a focus on major developments over the past decade, current standards of care, and novel therapeutics that are expected to revolutionize the treatment of this aggressive malignancy.
    Journal
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Zepzelca (lurbinectedin) • Imdelltra (tarlatamab-dlle)
    1m
    Small cell lung cancer: a therapeutic update in the era of immunotherapy and beyond-a narrative review. (PubMed, Chin Clin Oncol)
    While immunotherapy has improved outcomes, most patients ultimately relapse. Integrating molecular subtyping, optimizing multimodality care, and accelerating clinical trial enrollment are key to further progress in SCLC.
    Review • Journal
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Tecentriq (atezolizumab) • Imfinzi (durvalumab) • etoposide IV • Zepzelca (lurbinectedin) • Imdelltra (tarlatamab-dlle)
    1m
    Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo) (clinicaltrials.gov)
    P3, N=455, Active, not recruiting, PharmaMar | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    doxorubicin hydrochloride • Zepzelca (lurbinectedin)
    1m
    Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON) (clinicaltrials.gov)
    P3, N=705, Completed, PharmaMar | Active, not recruiting --> Completed
    Trial completion
    |
    irinotecan • topotecan • Zepzelca (lurbinectedin)
    2ms
    The Use of Fam-Trastuzumab Deruxtecan-nxki in Treating ERBB2 Amplified Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer: A Case Report. (PubMed, Case Rep Oncol Med)
    We present a case of a 66-year-old female with de novo metastatic NSCLC harboring an EGFR mutation, RET rearrangement, and ERBB2 amplification, who experienced transformation to SCLC while on osimertinib. Subsequently, she exhibited primary refractory disease to both first-line platinum doublet with immunotherapy and second-line lurbinectedin...The patient had minimal side effects and obtained a partial response with a progression-free survival (PFS) of 13.1 months, better than historically poor prognosis seen in transformed SCLC. This case underscores the potential role of human epidermal growth factor receptor 2 (HER-2) directed therapies, such as T-DXd, in transformed SCLC.
    Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • RET (Ret Proto-Oncogene)
    |
    EGFR mutation • HER-2 amplification • RET mutation • RET rearrangement
    |
    Tagrisso (osimertinib) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Zepzelca (lurbinectedin)
    2ms
    Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sichuan University | Initiation date: Dec 2025 --> Oct 2026
    Trial initiation date
    |
    albumin-bound paclitaxel • etoposide IV • irinotecan • Zepzelca (lurbinectedin)
    3ms
    Study of Trilaciclib and Lurbinectidin (clinicaltrials.gov)
    P2, N=30, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Zepzelca (lurbinectedin) • Cosela (trilaciclib)