Trials / Approved For Marketing
Approved For MarketingNCT04291937
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurbinectedin | Powder for concentrate for solution for infusion in 4 mg vials |
Timeline
- First posted
- 2020-03-02
- Last updated
- 2020-06-19
Source: ClinicalTrials.gov record NCT04291937. Inclusion in this directory is not an endorsement.