Back to resultsA Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
Primary Purpose
Small Cell Lung Cancer
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Lurbinectedin
Sponsored by
About this trial
This is an expanded access trial for Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04291937
Brief Title
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
Official Title
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Other Intervention Name(s)
PM01183
Intervention Description
Powder for concentrate for solution for infusion in 4 mg vials
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
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