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

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509602-29-00

Acronym

D933QC00001

Enrollment

168

Registered

2024-06-27

Start date

2019-02-11

Completion date

Unknown

Last updated

2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Limited Stage Small-Cell Lung Cancer (LS-SCLC)

Brief summary

PFS using BICR assessments according to RECIST 1.1 OS

Detailed description

PFS, ORR, PFS18, PFS24, and TTDM using BICR assessments according to RECIST 1.1 OS, OS24, OS36 PFS2 EORTC QLQ-C30 and QLQ-LC13: change in symptoms, functioning, and global health status/QoL Concentration of durvalumab and tremelimumab in serum (such as peak concentration and trough; sparse sampling) Presence of ADA for durvalumab and tremelimumab, PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS, and ORR). Safety assessment: AEs; laboratory findings including clinical chemistry, hematology, urinalysis; physical examinations; vital signs including blood pressure and pulse; and electrocardiograms

Interventions

DRUGINFLIXIMAB

DRUGSODIUM CHLORIDE

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGMYCOPHENOLATE MOFETIL

DRUGIMJUDO 20 mg/ml concentrate for solution for infusion.

DRUGDEXTROSE BP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS using BICR assessments according to RECIST 1.1 OS	—

Secondary

Measure	Time frame
PFS, ORR, PFS18, PFS24, and TTDM using BICR assessments according to RECIST 1.1 OS, OS24, OS36 PFS2 EORTC QLQ-C30 and QLQ-LC13: change in symptoms, functioning, and global health status/QoL Concentration of durvalumab and tremelimumab in serum (such as peak concentration and trough; sparse sampling) Presence of ADA for durvalumab and tremelimumab, PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS, and ORR). Safety assessment: AEs; laboratory findings including clinical chemistry, hematology, urinalysis; physical examinations; vital signs including blood pressure and pulse; and electrocardiograms	—

Measure

Time frame

—

Countries

Belgium, Czechia, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026