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NCT04291937 Clinical Trial

A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Small Cell Lung Cancer Clinical Trial

Official title:
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04291937
Other study ID # LUR_EAP-001-2019
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date June 2020
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lurbinectedin
Powder for concentrate for solution for infusion in 4 mg vials

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jazz Pharmaceuticals
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