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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:
    3d
    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
    6d
    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)
    8d
    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)
    23d
    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)
    26d
    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)
    28d
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    2ms
    SEZanne: A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, AbbVie | N=60 --> 180
    Enrollment change • Trial initiation date • Adverse events
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Zepzelca (lurbinectedin) • ABBV-706
    3ms
    SEZanne: A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, AbbVie | N=50 --> 180
    Enrollment change • Trial initiation date • Adverse events
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Zepzelca (lurbinectedin) • ABBV-706
    3ms
    SEZanne: A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, AbbVie | N=27 --> 50
    Enrollment change • Adverse events
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Zepzelca (lurbinectedin) • ABBV-706