Expanded Access Program for Lurbinectedin in Previously Treated Small Cell Lung Cancer in the USA
Sponsor: Jazz Pharmaceuticals
ClinicalTrials ID:NCT04291937
This program allows patients in the USA with small cell lung cancer, who have already received treatment, to access the drug lurbinectedin before it is approved by the FDA. Doctors will evaluate if the potential benefits of the treatment outweigh the risks for each patient.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This program provides access to the drug lurbinectedin for patients in the USA who have small cell lung cancer (SCLC) and have already undergone treatment. It is designed for patients who need this medication before it receives FDA approval. Medical sites must apply to be part of the program, and a doctor will decide if the treatment is suitable for each patient based on their medical history and the program's eligibility criteria.
Eligibility Criteria
Inclusion Criteria
- Must be an adult who can legally make medical decisions.
- Have a confirmed diagnosis of small cell lung cancer that cannot be removed by surgery.
- Must have already received one round of chemotherapy.
- Have good organ function, including blood, kidney, and liver health.
- Must have recovered from any side effects of previous treatments.
- Women must not be pregnant and must use an effective birth control method.
Exclusion Criteria
- Have not been treated with lurbinectedin before.
- Do not have certain other diseases or conditions.
- Do not have worsening brain issues that require steroids.
- Women who are pregnant or breastfeeding cannot participate.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.