Clinical Trials

Numerous clinical trials have evaluated lurbinectedin across various advanced malignancies, prominently including small cell lung cancer, leiomyosarcoma, Ewing sarcoma, endometrial cancer, and neuroendocrine tumors. Ranging from early-phase safety and pharmacokinetic assessments to pivotal trials, these studies evaluate monotherapy and combination regimens sponsored by academic medical centers and industry leaders, such as PharmaMar, Jazz Pharmaceuticals, the National Cancer Institute, and the Mayo Clinic. Protocol statuses across this portfolio range from active recruiting and enrolled by invitation to completed and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07328425 RECRUITING
Desmoplastic Small Round Cell Tumor
Italian Sarcoma Group
 2025-11-21 PHASE2
NCT07365241 RECRUITING
Small Cell Lung Cancer
AbbVie
 2026-07-02 PHASE3
NCT07796100 NOT_YET_RECRUITING
Extensive-Stage Small Cell Lung Cancer
Zai Lab (Shanghai) Co., Ltd.
 2026-12-31 PHASE3
NCT07141771 NOT_YET_RECRUITING
SCLC, Extensive Stage
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2025-12-31 PHASE1; PHASE2
NCT07625644 NOT_YET_RECRUITING
Small Cell Lung Cancer Extensive Stage; Small-cell Lung Cancer; Small Cell Carcinoma; Sclc; SCLC,Extensive Stage; Lung Cancer; Lung Cancer Metastatic; Lung Cancer Stage IV
SystImmune Inc.
 2026-06 PHASE3
NCT06681220 RECRUITING
Relapsed Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
VA Office of Research and Development
 2026-02-23 PHASE1; PHASE2
NCT06801834 RECRUITING
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Gilead Sciences
 2025-04-04 PHASE3
NCT06088290 ACTIVE_NOT_RECRUITING
Leiomyosarcoma
PharmaMar
 2023-09-21 PHASE3
NCT07155174 RECRUITING
Small Cell Lung Cancer
AbbVie
 2025-11-25 PHASE2
NCT07153055 RECRUITING
Small Cell Lung Cancer ( SCLC ); Transformed Small Cell Lung Cancer
Misty Shields
 2026-08 PHASE1; PHASE2
NCT05800587 RECRUITING
Lung Cancer; Small-cell Lung Cancer; Non Small Cell Lung Cancer
Fox Chase Cancer Center
 2023-02-22 PHASE2
NCT05918640 RECRUITING
Ewing Sarcoma; Desmoplastic Small Round Cell Tumor; Pediatric Cancer; Undifferentiated Sarcoma
Children's Hospital of Philadelphia
 2023-07-27 PHASE1; PHASE2
NCT07459634 RECRUITING
Extensive-stage Small-cell Lung Cancer
Jazz Pharmaceuticals
 2026-08-30 PHASE2
NCT06203210 RECRUITING
Small Cell Lung Cancer
Daiichi Sankyo
 2024-05-21 PHASE3
NCT05734066 RECRUITING
Refractory Ewing Sarcoma; Relapsed Ewing Sarcoma; Ewing Sarcoma
Jazz Pharmaceuticals
 2023-05-23 PHASE1; PHASE2
NCT06496048 RECRUITING
Relapsed Small Cell Lung Cancer
Luye Pharma Group Ltd.
 2024-09-14 PHASE3
NCT07258147 NOT_YET_RECRUITING
Lung Cancer (SCLC)
Sichuan University
 2026-10-31 PHASE2
NCT05652686 RECRUITING
Small Cell Lung Cancer (SCLC); Large Cell Neuroendocrine Cancer (LCNEC); Neuroendocrine Prostate Cancer (NEPC); Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC); Neuroendocrine Carcinomas (NEC); Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
Phanes Therapeutics
 2023-09-05 PHASE1; PHASE2
NCT06228066 RECRUITING
Small Cell Carcinoma of the Bladder; High Grade Neuroendocrine Tumors of the Urinary Tract
National Cancer Institute (NCI)
 2024-06-13 PHASE2
NCT07640932 NOT_YET_RECRUITING
Carcinoma, Small Cell Lung
Yonsei University
 2026-11 PHASE2
NCT07121478 ENROLLING_BY_INVITATION
Neuroendocrine Tumor of Pancreas; Pancreatic Neuroendocrine Tumors
National Cancer Center, Korea
 2025-09-23 PHASE2
NCT05636111 RECRUITING
Ovarian Cancer
M.D. Anderson Cancer Center
 2023-07-12 PHASE1
NCT05578326 RECRUITING
Lung Cancer; Small-cell Lung Cancer
UNC Lineberger Comprehensive Cancer Center
 2022-10-12 PHASE2
NCT06497530 RECRUITING
Extensive-Stage Small Cell Lung Cancer
Guangzhou Institute of Respiratory Disease
 2024-12-01 PHASE2
NCT06501976 ACTIVE_NOT_RECRUITING
Small Cell Lung Carcinoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2025-12-31 PHASE2
NCT05099666 ACTIVE_NOT_RECRUITING
Advanced Soft-tissue Sarcoma; Metastatic Soft-tissue Sarcoma; Advanced Leiomyosarcoma; Leiomyosarcoma Metastatic
Massachusetts General Hospital
 2022-02-04 PHASE1; PHASE2
NCT05574504 WITHDRAWN
Metastatic Cancer; Urothelial Carcinoma
AdventHealth
 2023-05-08 PHASE2
NCT04607954 ACTIVE_NOT_RECRUITING
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
Mayo Clinic
 2020-12-04 PHASE2
NCT05244239 RECRUITING
Extensive Stage Lung Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8
Emory University
 2022-07-27 PHASE1
NCT05876715 RECRUITING
Advanced Soft-tissue Sarcoma
ERLINDA M GORDON
 2023-06-07 PHASE1; PHASE2
NCT06217536 WITHDRAWN
Locally Advanced Soft Tissue Sarcoma
University of California, San Francisco
 2024-10-31 PHASE1; PHASE2
NCT05153239 COMPLETED
Relapsed Small Cell Lung Cancer
PharmaMar
 2022-07-22 PHASE3
NCT04802174 ACTIVE_NOT_RECRUITING
SCLC; Small Cell Cancer; Advanced Solid Tumor; High Grade Neuroendocrine Cancers
National Cancer Institute (NCI)
 2021-06-01 PHASE1; PHASE2
NCT05229588 COMPLETED
Gastrointestinal Malignancies
HonorHealth Research Institute
 2022-06-14 PHASE2
NCT02611024 COMPLETED
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
PharmaMar
 2016-05-06 PHASE1; PHASE2
NCT05101265 UNKNOWN
Advanced Solid Tumor; Hepatic Impairment
PharmaMar
 2021-03-09 PHASE1
NCT05740566 ACTIVE_NOT_RECRUITING
Small Cell Lung Cancer (SCLC)
Amgen
 2023-05-31 PHASE3
NCT05091567 ACTIVE_NOT_RECRUITING
Small-Cell Lung Cancer
Hoffmann-La Roche
 2021-11-18 PHASE3
NCT05572476 WITHDRAWN
Small Cell Lung Cancer; Platinum-Sensitive Lung Small Cell Carcinoma; Extensive-stage Small-cell Lung Cancer
Institut Bergonié
 2023-10 PHASE2
NCT06385548 WITHDRAWN
Endometrial Cancer
Vall d'Hebron Institute of Oncology
 2024-05 PHASE1; PHASE2
NCT06385548 Not yet recruiting
Endometrial Cancer
Vall d''Hebron Institute of Oncology
 2024-05 Phase 1|Phase 2
NCT06228066 Recruiting
Small Cell Carcinoma of the Bladder|High Grade Neuroendocrine Tumors of the Urinary Tract
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2024-05-15 Phase 2
NCT05126433 TERMINATED
Advanced Solid Tumor; Metastatic Solid Tumor; Urothelial Cancer; Poorly Differentiated Neuroendocrine Carcinomas; Homologous Recombination Deficient-Positive Malignancies Agnostic
Jazz Pharmaceuticals
 2022-03-03 PHASE2
NCT04638491 COMPLETED
Advanced Solid Tumor
Luye Pharma Group Ltd.
 2020-11-24 PHASE1
NCT04358237 COMPLETED
Small Cell Lung Carcinoma
Antonio Calles Blanco
 2020-09-21 PHASE1; PHASE2
NCT06088290 Recruiting
Leiomyosarcoma
PharmaMar
 2023-09-21 Phase 2|Phase 3
NCT05734066 Recruiting
Refractory Ewing Sarcoma|Relapsed Ewing Sarcoma|Ewing Sarcoma
Jazz Pharmaceuticals
 2023-05-23 Phase 1|Phase 2
NCT04610658 TERMINATED
Small-cell Lung Cancer; Relapsed Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2020-11-23 PHASE1
NCT05042934 WITHDRAWN
Metastatic Ewing Sarcoma; Recurrent Ewing Sarcoma
M.D. Anderson Cancer Center
 2021-09-15 PHASE1; PHASE2
NCT05063318 COMPLETED
Advanced Solid Tumors
PharmaMar
 2020-10-07 PHASE1
NCT05072106 COMPLETED
Advanced Solid Tumor
PharmaMar
 2021-01-14 PHASE1
NCT03213301 COMPLETED
Malignant Pleural Mesothelioma, Advanced
Swiss Cancer Institute
 2017-09-28 PHASE2
NCT02454972 COMPLETED
Advanced Solid Tumors
PharmaMar
 2015-08-25 PHASE2
NCT02566993 COMPLETED
Small-cell Lung Cancer
PharmaMar
 2016-08-30 PHASE3
NCT02421588 COMPLETED
Ovarian Cancer
PharmaMar
 2015-05 PHASE3
NCT01970540 COMPLETED
Endometrial Adenocarcinomas; Neuroendocrine Tumors; Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy
PharmaMar
 2011-05-25 PHASE1
NCT01980667 COMPLETED
Advanced Solid Tumors
PharmaMar
 2014-07-30 PHASE1
NCT01951157 COMPLETED
Non-Small Cell Lung Cancer (NSCLC)
PharmaMar
 2013-09-11 PHASE2
NCT02210364 COMPLETED
Metastatic Breast Cancer; Pancreatic Cancer; Metastatic Colorectal Cancer
PharmaMar
 2013-04 PHASE1
NCT02451007 COMPLETED
Solid Tumors
PharmaMar
 2015-08-12 PHASE2
NCT01831089 COMPLETED
Breast Cancer; Ovarian Cancer; Gynecological Cancer; Head and Neck Carcinoma; Non-small Cell Lung Cancer; Small Cell Lung Cancer; Non-squamous Cell Lung Cancer
PharmaMar
 2013-09 PHASE1
NCT01314599 COMPLETED
Acute Leukemia
PharmaMar
 2011-05 PHASE1
NCT01970553 COMPLETED
Specific Advanced Solid Tumors
PharmaMar
 2011-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Lurbinectedin (PM01183) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lurbinectedin covalently binds to residues in the minor groove of DNA, which impairs active transcription through the inhibition of RNA polymerase II and causes double-strand DNA breaks that lead to apoptotic cell death. This potent cytotoxic activity arrests cancer cell proliferation and drives tumor regression, providing therapeutic efficacy in clinical indications such as small cell lung cancer and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.