Studieoverzicht

Study name: DeLLphi-305

Histology SCLC
Tumor stage Stage IV
Host / recruiting sites Erasmus MC, MUMC+
Enrollment Planned
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