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

NCT ID: NCT04291937

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Small Cell Lung Cancer

Interventions

Lurbinectedin

Powder for concentrate for solution for infusion in 4 mg vials

Intervention Type: DRUG

Other Intervention Names

PM01183

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LUR_EAP-001-2019

Identifier Type: -

Identifier Source: org_study_id