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

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ClinicalTrials.gov Identifier: NCT04291937
Expanded Access Status : Approved for marketing
First Posted : March 2, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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
Small Cell Lung Cancer Drug: Lurbinectedin

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



Intervention Details:
  • Drug: Lurbinectedin
    Powder for concentrate for solution for infusion in 4 mg vials
    Other Name: PM01183

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

No Contacts or Locations Provided
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04291937    
Other Study ID Numbers: LUR_EAP-001-2019
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms