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

Sponsor: Jazz Pharmaceuticals

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04291937

Patient View

This expanded access program allows eligible U.S. patients with previously treated, unresectable SCLC to receive lurbinectedin, a drug in 4 mg vials for infusion. Participants must be legally competent adults with adequate organ function, have recovered from prior treatment toxicities, and use contraception if applicable. A medical doctor will assess the risk-benefit ratio for each patient.

Patient Parameters

Program Overview

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.

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.

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You can sign up and apply your patients for this program.