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

Primary Purpose

Small Cell Lung Cancer

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Lurbinectedin
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2020
    Last Updated
    June 17, 2020
    Sponsor
    Jazz Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04291937
    Brief Title
    A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
    Official Title
    A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jazz Pharmaceuticals

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Cell Lung Cancer

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lurbinectedin
    Other Intervention Name(s)
    PM01183
    Intervention Description
    Powder for concentrate for solution for infusion in 4 mg vials

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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