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

Prior treatment

• Active or prior documented autoimmune or inflammatory disorders
• Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

Other illness

• Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
• Active infection including tuberculosis, HIV, hepatitis B and C

Other

• Extensive-stage SCLC

• 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.
  • 4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.