{"commentary":{"count":6,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":6},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"ADRIATIC","nct_id":"NCT03703297","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=adriatic-nct03703297. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"ADRIATIC","arms":[{"description":"Durvalumab monotherapy: Durvalumab (1500 mg intravenous \\[IV\\]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.","label":"Durvalumab + Placebo","type":"EXPERIMENTAL"},{"description":"Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.","label":"Durvalumab + Tremelimumab","type":"EXPERIMENTAL"},{"description":"Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.","label":"Placebo + Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-10-23","type":"ESTIMATED"},"conditions":["Small Cell Lung Cancer"],"enrollment":{"count":730,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Durvalumab","type":"DRUG"},{"name":"Tremelimumab","type":"DRUG"},{"name":"Placebo","type":"OTHER"}],"last_update":"2025-11-21","lead_sponsor":"AstraZeneca","official_title":"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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-01-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1","timeFrame":"Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)"},{"measure":"Durvalumab Versus Placebo: Overall Survival (OS)","timeFrame":"From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)"}],"references":[{"citation":"Su H, Zhao BJ, Fu Y, Zhang YY, Chugh P, Casson E, Lim K, Ren S, Zhou D, Ma P, Fan C. Population Pharmacokinetics and Exposure-response Analysis of Durvalumab in Patients with Limited-stage Small-cell Lung Cancer in the Phase 3 ADRIATIC Study. AAPS J. 2026 Sep 28;28(6):162. doi: 10.1208/s12248-026-01295-y.","pmid":"42806195","type":"DERIVED"},{"citation":"Senan S, Cho BC, Laktionov KK, Zenke Y, Lee KH, Wang Q, Navarro A, Buchmeier EL, Goksu SS, Badzio A, Shi A, Daniel DB, Zemanova M, Iyengar P, Paz-Ares L, Szadkowski L, Chugh P, Lai WV, Spigel DR. Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic Cranial Irradiation in the Phase 3 ADRIATIC Trial. J Thorac Oncol. 2026 Aug;21(8):103703. doi: 10.1016/j.jtho.2026.103703. Epub 2026 Mar 30.","pmid":"41921748","type":"DERIVED"},{"citation":"Zenke Y, Shiraishi Y, Goto Y, Azuma K, Okishio K, Ogino H, Horio Y, Oizumi S, Hayama M, Nii M, Harada M, Mann H, Olivo YS, Jiang H, Senan S. Durvalumab Post Concurrent Chemoradiotherapy in Japanese Patients With Limited-Stage Small-Cell Lung Cancer in the Phase 3 ADRIATIC Trial. Cancer Sci. 2025 Nov;116(11):3171-3184. doi: 10.1111/cas.70188. Epub 2025 Sep 21.","pmid":"40976711","type":"DERIVED"},{"citation":"Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Sezgin Goksu S, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327. doi: 10.1056/NEJMoa2404873. Epub 2024 Sep 13.","pmid":"39268857","type":"DERIVED"},{"citation":"Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28.","pmid":"31948903","type":"DERIVED"}],"start_date":{"date":"2018-09-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy","url":"https://clinicaltrials.gov/study/NCT03703297"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/adriatic-nct03703297"}