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.
Brief Title
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
Categories
Conditions
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04291937
Org Class
Industry
Org Full Name
Jazz Pharmaceuticals
Org Study Id
LUR_EAP-001-2019
Overall Status
Approved for marketing
Official Title
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone