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

Sponsor
Jazz Pharmaceuticals (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT04291937
Collaborator
(none)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jazz Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jazz Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04291937
    Other Study ID Numbers:
    • LUR_EAP-001-2019
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    Jun 19, 2020
    Last Verified:
    Jun 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2020