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

Jazz Pharmaceuticals

Status

Conditions: Small Cell Lung Cancer

Treatments: Drug: Lurbinectedin

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04291937

LUR_EAP-001-2019

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.