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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04291937
Enrollment
Unknown
Registered
2020-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2020-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

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.

Interventions

DRUGLurbinectedin

Powder for concentrate for solution for infusion in 4 mg vials

Sponsors

Jazz Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026