Jazz Pharmaceuticals
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first line (1L) induction therapy.
The study will evaluate the safety and efficacy of lurbinectedin in combination with durvalumab as maintenance therapy in participants with ES-SCLC after first line induction therapy with durvalumab and platinum plus etoposide containing regimen. In order to be considered for eligibility screening for the maintenance phase, participants need to have an ongoing CR, PR, or stable disease (SD) per RECIST v1.1 criteria after completion of 4 cycles of platinum plus etoposide containing regimen with at least 3 cycles of durvalumab during induction treatment.
Inclusion Criteria: 1. Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system). 2. Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab 3. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician. 5. Adequate hematologic and end-organ function for at least 7 days prior to dosing. 6. Has a body weight \> 30 kg. 7. Adequate contraceptive precautions. Exclusion…
Administered by intravenous (IV) infusion
Administered by intravenous (IV) infusion