{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"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":"AEGEAN","nct_id":"NCT03800134","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=aegean-nct03800134. 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":"AEGEAN","arms":[{"description":"Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity\n\nThe platinum-based chemotherapy will be based on tumour histology and Investigator discretion:\n\n* cisplatin with pemetrexed\n* carboplatin with pemetrexed\n* carboplatin with paclitaxel\n* cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)","label":"Arm 1: Durvalumab with platinum-based chemotherapy","type":"EXPERIMENTAL"},{"description":"Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity\n\nThe platinum-based chemotherapy will be based on tumour histology and Investigator discretion:\n\n* cisplatin with pemetrexed\n* carboplatin with pemetrexed\n* carboplatin with paclitaxel\n* cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)","label":"Arm 2: Placebo with platinum-based chemotherapy","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-09-11","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":825,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Durvalumab","type":"DRUG"},{"name":"Placebo","type":"OTHER"},{"name":"Carboplatin","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Pemetrexed","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Surgery","type":"PROCEDURE"}],"last_update":"2025-06-11","lead_sponsor":"AstraZeneca","official_title":"A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2022-11-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population","timeFrame":"Up to approximately 15 weeks after randomization"},{"measure":"Event-Free Survival (EFS) in modified intent to treat (mITT) population","timeFrame":"Up to 5.5 years after first patient randomized."}],"references":[{"citation":"Mitsudomi T, Heymach JV, Horio Y, Tanaka F, Tanaka H, Kuyama S, Okada M, Toyooka S, Watanabe Y, Reck M, Harpole D, Taube JM, Olivo Y, Xiong H, Fouad TM, Chen A, Akamatsu H. Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes for Japanese Patients in AEGEAN. Cancer Sci. 2026 Sep 27:10.1111/cas.70541. doi: 10.1111/cas.70541. Online ahead of print.","pmid":"42802029","type":"DERIVED"},{"citation":"Mitsudomi T, Heymach JV, Reck M, Taube JM, Gao S, Horio Y, You J, Li G, Van Luong D, Saeteng S, Tanaka F, Watzka SB, Urban L, Szalai Z, Akamatsu H, Kang JH, Orlandi FJ, Mukhametshina GZ, Pircher A, Teixeira CHA, Aperghis M, Doherty GJ, Doake R, Fouad TM, Harpole D. Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC. J Thorac Oncol. 2025 Nov;20(11):1639-1654. doi: 10.1016/j.jtho.2025.06.015. Epub 2025 Jun 20.","pmid":"40545237","type":"DERIVED"},{"citation":"Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.","pmid":"37870974","type":"DERIVED"}],"start_date":{"date":"2018-12-06","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer","url":"https://clinicaltrials.gov/study/NCT03800134"},"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/aegean-nct03800134"}