A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
1 other identifier
expanded_access
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0 countries
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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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedJune 19, 2020
June 1, 2020
February 27, 2020
June 17, 2020
Conditions
Interventions
Powder for concentrate for solution for infusion in 4 mg vials
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with lurbinectedin
- Certain concomitant diseases/conditions
- Symptomatic, steroid-requiring or progressive CNS involvement.
- Pregnant or breast-feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 2, 2020
Last Updated
June 19, 2020
Record last verified: 2020-06