Status:
APPROVED_FOR_MARKETING
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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 pa...
Eligibility Criteria
Inclusion
- 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
- Prior treatment with lurbinectedin
- Certain concomitant diseases/conditions
- Symptomatic, steroid-requiring or progressive CNS involvement.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04291937
Last Update
June 19 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.