NCT03703297

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

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab IV (intravenous infusion)
DRUG	Tremelimumab	Tremelimumab IV (intravenous infusion)
OTHER	Placebo	Placebo IV (intravenous infusion)

Timeline

• Start date: 2018-09-27
• Primary completion: 2024-01-15
• Completion: 2026-10-23
• First posted: 2018-10-11
• Last updated: 2025-11-21
• Results posted: 2025-08-01

Locations

183 sites across 19 countries: United States, Argentina, Belgium, Canada, China, Czechia, Germany, India, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study