{"entity":{"id":"nct03800134","kind":"trial","name":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer","aka":["AEGEAN"],"tldr":"A phase 3 trial of Durvalumab, Carboplatin, Cisplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer is a phase 3 interventional study registered as NCT03800134 by AstraZeneca, with 825 participants enrolled, started 2018-12-06 and due to reach its primary completion in 2022-11-10. Interventions recorded: Durvalumab, Placebo, Carboplatin, Cisplatin, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03800134","url":"https://clinicaltrials.gov/study/NCT03800134"},{"label":"AEGEAN updated outcomes (Journal of Clinical Oncology 2026)","url":"https://doi.org/10.1200/JCO-25-02659"},{"label":"NICE TA1030: durvalumab with chemotherapy before surgery then alone after surgery for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1030"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","resectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","cisplatin","pemetrexed","paclitaxel","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["checkmate-816","keynote-671","nct04025879","neotorch"],"people":[],"bottlenecks":[],"keyPapers":["paper-heymach-aegean-perioperative-durvalumab-nejm-2023"],"journals":[],"dependsOn":[],"notes":["AEGEAN randomised patients with treatment-naive resectable stage II to IIIB(N2) disease 1:1 to four cycles of neoadjuvant platinum chemotherapy with durvalumab or placebo every three weeks, then twelve adjuvant cycles every four weeks. Efficacy was analysed in a modified intention-to-treat population of 740 that excluded documented EGFR and ALK aberrations. At the second planned interim analysis (data cutoff 10 May 2024, median follow-up 25.9 months) the event-free survival hazard ratio was 0.69 (0.55 to 0.88), with numerical improvements in disease-free survival (0.66, 0.47 to 0.92) and overall survival (0.89, 0.70 to 1.14). Maximum grade 3 or 4 adverse events during adjuvant treatment occurred in 15.4 percent on durvalumab and 10.6 percent on placebo (Journal of Clinical Oncology 2026)."],"nct":"NCT03800134","phase":"3","setting":"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)","sponsor":"AstraZeneca","result":"Perioperative durvalumab with neoadjuvant platinum chemotherapy improved event-free survival (hazard ratio 0.69, 95 percent confidence interval 0.55 to 0.88 at the second interim analysis) and pathological complete response in resectable stage II to IIIB(N2) non-small-cell lung cancer.","started":"2018-12-06","startedType":"actual","yearReported":2023,"enrolled":825,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03800134/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"nct04025879","kind":"trial","name":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer","route":"/trials/nct04025879/"},{"id":"checkmate-816","kind":"trial","name":"CheckMate 816","route":"/trials/checkmate-816/"},{"id":"nct04379635","kind":"trial","name":"Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)","route":"/trials/nct04379635/"},{"id":"keynote-671","kind":"trial","name":"KEYNOTE-671","route":"/trials/keynote-671/"},{"id":"neotorch","kind":"trial","name":"Neotorch","route":"/trials/neotorch/"}],"paper":[{"id":"paper-heymach-aegean-perioperative-durvalumab-nejm-2023","kind":"paper","name":"Perioperative durvalumab for resectable non-small-cell lung cancer","route":"/key-papers/paper-heymach-aegean-perioperative-durvalumab-nejm-2023/"}]}}