| Histology |
SCLC
|
| Tumor stage |
Stage III - IV |
| Host / recruiting site 1 |
Erasmus MC
|
Enrollment |
Closed
|
| Host / recruiting site 2 |
MUMC+
|
Enrollment |
Closed
|
| Therapy line |
First line (1L)
|
| Design |
- Randomized, open-label, multicenter, phase III
|
| Intervention |
- Arm A: Tarlatamab and Durvalumab
- Arm B: Durvalumab
|
| Key outcome parameters |
- To compare the efficacy amd safety of Tarlatamab and durvalumab with durvalumab alone on prolonging overall survival
|
| Key inclusion criteria |
- Histologically or cytologically documented estensive-stage disease IV, SCLC or T3 to T4 due to multiple lung nodules that are too extensive of have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- Completed 4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first line treatment, without disease progression
- ECOG status of 0 or 1
|
| Key exclusion criteria |
- Symptomatic central nervous system metastases, or leptomeningeal disease
- Systemic corticosteroid therapy of any other form of immunosuppresiive therapy within 14 days prior to first dose of study treatment
|
| Contact information |
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|
