Konsolidierende Immuntherapie (Durvalumab +/- Tremelimumab) nach Strahlen-Chemotherapie des kleinzelligen Bronchialkarzinoms
This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
- Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
- Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
- PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
- Have not progressed following definitive concurrent chemoradiation
- Life expectancy ≥ 12 weeks at Day 1.
- ECOG 0 or 1 at enrolment.
- Extensive-stage SCLC
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
- Active infection including tuberculosis, HIV, hepatitis B and C
- Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)