| Zepzelca (lurbinectedin) / PharmaMar, Jazz |
IDeate-Lung02, NCT06203210: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer |
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| Recruiting | 3 | 540 | Europe, Canada, Japan, US, RoW | Ifinatamab deruxtecan, I-DXd, Topotecan, Amrubicin, Lurbinectedin | Daiichi Sankyo, Merck Sharp & Dohme LLC | Small Cell Lung Cancer | 04/27 | 02/29 | | |
NCT06496048: Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC |
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| Recruiting | 3 | 180 | RoW | Lurbinectedin, PM01183, Irinotecan, Topotecan | Luye Pharma Group Ltd. | Relapsed Small Cell Lung Cancer | 12/27 | 06/28 | | |
| Active, not recruiting | 3 | 509 | Europe, Canada, Japan, US, RoW | Tarlatamab, AMG 757, Lurbinectedin, Topotecan, Amrubicin | Amgen | Small Cell Lung Cancer (SCLC) | 07/27 | 07/27 | | |
IMforte, NCT05091567 / 2021-001930-20: A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer |
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| Active, not recruiting | 3 | 690 | Europe, US, RoW | Atezolizumab, Tecentriq, RO5541267, Lurbinectedin, PM01183/JZP712, Carboplatin, Etoposide | Hoffmann-La Roche, Jazz Pharmaceuticals | Small-Cell Lung Cancer | 04/25 | 03/26 | | |
LAGOON, NCT05153239 / 2021-004471-13: Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer |
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| Active, not recruiting | 3 | 705 | Europe, Canada, Japan, US, RoW | Irinotecan, Lurbinectedin, PM01183, Topotecan | PharmaMar, Pharma Mar, S.A. | Relapsed Small Cell Lung Cancer | 04/26 | 04/26 | | |
NCT06088290: Study of Lurbinectedin in Combination with Doxorubicin Versus Doxorubicin Alone As First-line Treatment in Participants with Metastatic Leiomyosarcoma |
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| Recruiting | 2/3 | 360 | Europe, US | Lurbinectedin, Doxorubicin | PharmaMar | Leiomyosarcoma | 11/26 | 11/26 | | |
| Completed | 2 | 47 | US | Lurbinectedin | Jazz Pharmaceuticals | Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas, Homologous Recombination Deficient-Positive Malignancies Agnostic | 12/23 | 12/23 | | |
LASER, NCT06228066: Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder |
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| Recruiting | 2 | 45 | US | Lurbinectedin, Avelumab | National Cancer Institute (NCI) | Small Cell Carcinoma of the Bladder, High Grade Neuroendocrine Tumors of the Urinary Tract | 09/27 | 09/28 | | |
NCT06501976: An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy |
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| Not yet recruiting | 2 | 9 | NA | Lurbinectedin, PM01183, Zepzelca, Radiation Therapy | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Small Cell Lung Carcinoma | 03/25 | 12/25 | | |
| Recruiting | 2 | 30 | US | Trilaciclib, Lurbinectedin | UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc. | Lung Cancer, Small-cell Lung Cancer | 12/25 | 12/27 | | |
| Not yet recruiting | 2 | 30 | NA | Serplulimab, Lurbinectedin, PM01183, Carboplatin, Etoposide | Guangzhou Institute of Respiratory Disease | Extensive-Stage Small Cell Lung Cancer | 06/25 | 12/25 | | |
| Withdrawn | 2 | 82 | Europe | Association of lurbinectedin and durvalumab, Association of carboplatin and etoposide | Institut Bergonié, AstraZeneca, PharmaMar | Small Cell Lung Cancer, Platinum-Sensitive Lung Small Cell Carcinoma, Extensive-stage Small-cell Lung Cancer | 05/24 | 05/24 | | |
NCT04607954: Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer |
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| Recruiting | 2 | 46 | US | Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, Lurbinectedin, PM01183, Zepzelca | Mayo Clinic, National Cancer Institute (NCI) | Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma, Recurrent Extensive Stage Lung Small Cell Carcinoma, Refractory Extensive Stage Lung Small Cell Carcinoma | 11/25 | 11/26 | | |
| Not yet recruiting | 2 | 152 | US | PARP inhibitor/Temozolomide, PARP inhibitor/TEMODAR, Lurbinectedin, Zepzelca | VA Office of Research and Development | Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer | 12/29 | 12/30 | | |
NCT05229588: Lurbinectedin in Patients With Advanced Gastrointestinal Malignancies With DNA Repair Mutations |
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| Recruiting | 2 | 19 | US | Lurbinectedin 4 MG Injection [Zepzelca], PM01183 | HonorHealth Research Institute, Jazz Pharmaceuticals | Gastrointestinal Malignancies | 08/25 | 08/26 | | |
ChiCTR2400084825: Lurbinectedin and doxorubicin plus regorafenib and PD-1 inhibitor as first-line treatment of locally advanced nonresectable or metastatic Soft Tissue Sarcoma: a prospective phase Ⅱ trial |
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| Not yet recruiting | 2 | 38 | | Lurbinectedin combined with doxorubicin plus PD-1 inhibitor and regorafenib | Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences, Lurbinectedin used in this trial will be provided by Hong Kong Cancer Prevention and Treatment Foundation(HKCPT) for free | Soft Tissue Sarcoma | | | | |
NCT05574504: Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy |
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| Withdrawn | 2 | 36 | US | avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin | AdventHealth, Jazz Pharmaceuticals | Metastatic Cancer, Urothelial Carcinoma | 11/26 | 11/28 | | |
NCT05800587: Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer |
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| Recruiting | 2 | 280 | US | Carboplatin, Pemetrexed, Paclitaxel, Nab paclitaxel, Docetaxel, Gemcitabine, Etoposide, Irinotecan, Topotecan, Lurbinectedin | Fox Chase Cancer Center | Lung Cancer, Small-cell Lung Cancer, Non Small Cell Lung Cancer | 08/28 | 08/29 | | |
2019-001553-12: Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients with Advanced Small Cell Lung Cancer that Progressed Following Prior Therapy with Platinum-Based Chemotherapy Estudio de fase I-II para evaluar la seguridad, tolerabilidad y eficacia de PM01183 y atezolizumab en pacientes con cáncer de pulmón de células pequeñas avanzado que hayan progresado tras una quimioterapia previa de platino |
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| Not yet recruiting | 1/2 | 25 | Europe | PM01183, Concentrate for solution for infusion, Lyophilisate for solution for infusion, Tecentriq | Fundacion ONCOSUR, Fundación ONCOSUR | Histologically or cytologically confirmed diagnosis of extensive or limited SCLC.Progression to first-line platinum-based chemotherapy.Measurable disease according to RECIST v.1.1. Diagnóstico confirmado histológica o citológicamente de SCLC extenso o limitado.Progresión a la quimioterapia de primera línea a base de platino.Progresión documentada de la enfermedad según RECIST v1.1, diagnosis of small cell lung cancer,progression after treatment with other drugs diagnostico de cáncer de pulmón de células pequeñas,progresión tras tratamiento con otros medicamentos, Diseases [C] - Cancer [C04] | | | | |
| Recruiting | 1/2 | 184 | Europe | PM 01183, Lurbinectidin, Atezolizumab, Tecentriq | Fundacion Oncosur, Fundación ONCOSUR | Carcinoma, Small Cell Lung | 05/25 | 05/25 | | |
2015-003602-16: Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Patients with Advanced Solid Tumors Studio clinico e farmacocinetico di Lurbinectedina in combinazione con Irinotecan in pazienti con tumori solidi avanzati |
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| Not yet recruiting | 1/2 | 320 | Europe | Lurbinectedina, Irinotecan, [PM01183], [NA], Powder for concentrate for solution for infusion, Concentrate for solution for injection/infusion | PHARMA MAR, S.A. SOCIEDAD UNIPERSONAL, Pharma Mar S.A., Pharma Mar S.A. | Selected Advanced Solid Tumors Tumori solidi avanzati selezionati, Advanced Solid Tumors Tumori solidi avanzati, Diseases [C] - Cancer [C04] | | | | |
| Active, not recruiting | 1/2 | 28 | Europe | Lurbinectedin, PM01183, Zepsyre, Pembrolizumab, Keytruda | Antonio Calles Blanco, MedSIR, PharmaMar, Merck Sharp & Dohme LLC | Small Cell Lung Carcinoma | 09/23 | 03/25 | | |
| Recruiting | 1/2 | 320 | Europe, US | Lurbinectedin, PM01183, Irinotecan | PharmaMar, Pharma Mar S.A. | Advanced Solid Tumors, Glioblastoma, Soft Tissue Sarcoma (Excluding GIST), Endometrial Carcinoma, Epithelial Ovarian Carcinoma, Mesothelioma, Gastroenteropancreatic Neuroendocrine Tumor, SCLC, Gastric Carcinoma, Pancreatic Adenocarcinoma, Colorectal Carcinoma, Neuroendocrine Tumors | 03/26 | 03/26 | | |
LiDer, NCT06385548: Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - |
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| Not yet recruiting | 1/2 | 15 | NA | Lurbinectedin, Dostarlimab | Vall d'Hebron Institute of Oncology | Endometrial Cancer | 05/24 | 04/26 | | |
| Active, not recruiting | 1/2 | 62 | US | Lurbinectedin, Zepzelca, Doxorubicin, Adriamycin | Massachusetts General Hospital, Jazz Pharmaceuticals | Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma, Advanced Leiomyosarcoma, Leiomyosarcoma Metastatic | 07/25 | 07/25 | | |
NCT06217536: Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas |
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| Withdrawn | 1/2 | 70 | NA | Lurbinectedin, Zepzelca, Radiotherapy, Radiation therapy, Non-investigational surgery | University of California, San Francisco, Jazz Pharmaceuticals | Locally Advanced Soft Tissue Sarcoma | 05/26 | 10/27 | | |
NCT04802174: Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers |
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| Recruiting | 1/2 | 120 | US | Lurbinectedin, Berzosertib | National Cancer Institute (NCI) | SCLC, Small Cell Cancer, Advanced Solid Tumor, High Grade Neuroendocrine Cancers | 08/26 | 12/27 | | |
| Recruiting | 1/2 | 40 | US | Lurbinectedin, Ipilimumab, Nivolumab | ERLINDA M GORDON | Advanced Soft-tissue Sarcoma | 06/26 | 09/26 | | |
| Recruiting | 1/2 | 56 | US | Lurbinectedin | Children's Hospital of Philadelphia, Jazz Pharmaceuticals, Stand Up To Cancer | Ewing Sarcoma, Desmoplastic Small Round Cell Tumor, Pediatric Cancer, Undifferentiated Sarcoma | 07/26 | 07/28 | | |
EMERGE 101, NCT05734066: Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma |
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| Recruiting | 1/2 | 60 | Canada, US | Lurbinectedin, JZP712 | Jazz Pharmaceuticals | Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma, Ewing Sarcoma | 12/26 | 06/27 | | |
NCT05072106: Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 8 | Europe | Lurbinectedin, PM01183, Bosentan | PharmaMar | Advanced Solid Tumor | 10/22 | 11/22 | | |
NCT05063318: Clinical Trial of Lurbinectedin (PM01183) in Patients With Advanced Solid Tumors |
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| Recruiting | 1 | 11 | Europe | Lurbinectedin alone, Lurbinectedin+Itraconazole co-administration | PharmaMar | Advanced Solid Tumors | 11/22 | 12/22 | | |
NCT04610658: Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC |
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| Terminated | 1 | 9 | US | Nivolumab, Opdivo, Ipilimumab, Yervoy, Lurbinectedin | H. Lee Moffitt Cancer Center and Research Institute, Bristol-Myers Squibb, Jazz Pharmaceuticals | Small-cell Lung Cancer, Relapsed Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer | 03/23 | 03/23 | | |
NCT05636111: Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer |
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| Recruiting | 1 | 34 | US | Paclitaxel, Taxol, Bevacizumab, Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Lurbinectedin | M.D. Anderson Cancer Center, Jazz Pharmaceuticals | Ovarian Cancer | 07/25 | 07/26 | | |
NCT04638491: Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients |
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| Completed | 1 | 32 | RoW | Lurbinectedin for injection, PM01183 | Luye Pharma Group Ltd. | Advanced Solid Tumor | 11/23 | 11/23 | | |
NCT05244239: Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer |
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| Recruiting | 1 | 22 | US | Lurbinectedin, PM01183, Zepzelca, Palliative Radiation Therapy, Palliative Radiotherapy | Emory University, National Cancer Institute (NCI), Jazz Pharmaceuticals | Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 | 01/25 | 01/25 | | |
NCT05101265: Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment |
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| Recruiting | 1 | 24 | Europe | Lurbinectedin, PM1183 | PharmaMar | Advanced Solid Tumor, Hepatic Impairment | 06/25 | 06/25 | | |
NCT06021483: Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection |
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| Recruiting | N/A | 300 | RoW | | Boryung Pharmaceutical Co., Ltd | SCLC | 09/25 | 09/25 | | |
EMERGE 402, NCT04894591: To Assess the Effectiveness and Safety of Zepzelca in Adult Patients With Extensive Stage Small Cell Lung Cancer (SCLC) |
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| Recruiting | N/A | 300 | Canada, US | Zepzelca, lurbinectedin | Jazz Pharmaceuticals | Extensive-stage Small-cell Lung Cancer | 06/30 | 06/30 | | |
