Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Stage I-III Limited Disease Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

Inclusion criteria:
1.Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
2.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.
3.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.
4 .Have not progressed following definitive concurrent chemoradiation
5 .Life expectancy ≥ 12 weeks at Day 1.
6. ECOG 0 or 1 at enrollment.
Phase III
Basir Haque, M.D.
Ernesto Ortiz Jr
  • Kadlec Clinic Hematology and Oncology
  • Kadlec Research