ADRIATIC

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224104

Enrollment

Registered

2018-10-22

Start date

2018-10-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Durvalumab, Tremelimumab INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Extensive-stage SCLC 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease. 4. Active infection including tuberculosis, HIV, hepatitis B and C 5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory -	—

Secondary

Measure	Time frame
safety efficacy exploratory -	—

Countries

Argentina, Belgium, Canada, China, Czech Republic, Germany, India, Mexico, Netherlands, Poland, Russia Federation, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States of America, Vietnam

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026