- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04291937
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
June 17, 2020 updated by: Jazz Pharmaceuticals
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval.
Sites must apply to participate in the program.
A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.
Study Overview
Status
Approved for marketing
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Legally competent adult
- Confirmed and unresectable Small Cell Lung Cancer (SCLC)
- Patients must have received one prior chemotherapy containing line
- Adequate organ, hematological, kidney, metabolic and liver function
- Recovery from toxicities related to previous treatment(s)
- Pregnancy must be excluded, medically acceptable contraception method
Exclusion Criteria:
- Prior treatment with lurbinectedin
- Certain concomitant diseases/conditions
- Symptomatic, steroid-requiring or progressive CNS involvement.
- Pregnant or breast-feeding women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
June 19, 2020
Last Update Submitted That Met QC Criteria
June 17, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUR_EAP-001-2019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Cell Lung Cancer
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
Washington University School of MedicineMerck Sharp & Dohme LLCWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Small Cell Lung Extensive Stage
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
Clinical Trials on Lurbinectedin
-
Children's Hospital of PhiladelphiaJazz Pharmaceuticals; Stand Up To CancerRecruitingEwing Sarcoma | Pediatric Cancer | Desmoplastic Small Round Cell Tumor | Undifferentiated SarcomaUnited States
-
Intergroupe Francophone de Cancerologie ThoraciquePharmaMar; Groupe Francais De Pneumo-CancerologieCompleted
-
Swiss Group for Clinical Cancer ResearchCompletedMalignant Pleural Mesothelioma, AdvancedSwitzerland, Italy
-
Jazz PharmaceuticalsRecruitingEwing Sarcoma | Refractory Ewing Sarcoma | Relapsed Ewing SarcomaUnited States, Canada
-
UNC Lineberger Comprehensive Cancer CenterG1 Therapeutics, Inc.Recruiting
-
Jazz PharmaceuticalsRecruitingExtensive-stage Small-cell Lung CancerUnited States, Canada
-
National Cancer Institute (NCI)RecruitingSCLC | Advanced Solid Tumor | Small Cell Cancer | High Grade Neuroendocrine CancersUnited States
-
Emory UniversityNational Cancer Institute (NCI); Jazz PharmaceuticalsRecruitingStage IV Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell CarcinomaUnited States
-
PharmaMarCompletedSolid TumorsSpain, United States
-
Luye Pharma Group Ltd.RecruitingAdvanced Solid TumorChina