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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

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dc.contributor.author조병철-
dc.date.accessioned2020-04-13T16:58:12Z-
dc.date.available2020-04-13T16:58:12Z-
dc.date.issued2020-
dc.identifier.issn1525-7304-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/175586-
dc.description.abstractLimited-stage (LS) small-cell lung cancer (SCLC) remains an area of high unmet medical need. The standard-of-care therapy comprises curative-intent platinum-based chemotherapy with concurrent radiotherapy (cCRT), which can be followed by prophylactic brain irradiation and then observation. However, most patients will relapse. Durvalumab (antiprogrammed cell death ligand-1) has enhanced the efficacy outcomes after cCRT for patients with unresectable, stage III non-small-cell lung cancer. Recently, durvalumab combined with platinum-etoposide demonstrated a significant survival benefit compared with platinum-etoposide as first-line treatment of patients with extensive-stage SCLC and has also shown antitumor activity as monotherapy and combined with tremelimumab (anticytotoxic T-lymphocyte-associated antigen-4) in pretreated patients with extensive-stage SCLC. ADRIATIC, a phase III, randomized, double-blind, placebo-controlled, multicenter, global study (ClinicalTrials.gov identifier, NCT03703297), is designed to investigate the efficacy of durvalumab, with or without tremelimumab, as consolidation therapy for patients with LS-SCLC without disease progression after cCRT. Approximately 600 patients with documented histologic or cytologic LS-SCLC, World Health Organization/Eastern Cooperative Oncology Group performance status 0 or 1, and no progression after 4 cycles of cCRT will be randomized (1:1:1) to treatment (durvalumab 1500 mg plus placebo every 4 weeks [q4w] for 4 cycles, followed by durvalumab 1500 mg q4w; durvalumab 1500 mg plus tremelimumab 75 mg q4w for 4 cycles, followed by durvalumab 1500 mg q4w; or dual placebo q4w for 4 cycles, followed by single placebo q4w) within 1 to 42 days of completing cCRT, stratified by stage and receipt of prophylactic brain irradiation. The primary endpoints are progression-free survival and overall survival. The secondary endpoints are overall survival and progression-free survival rates, objective response rate, and safety and tolerability. Recruitment began in September 2018.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfCLINICAL LUNG CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleDesign 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-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorSuresh Senan-
dc.contributor.googleauthorIsamu Okamoto-
dc.contributor.googleauthorGyeong-won Lee-
dc.contributor.googleauthorYuanbin Chen-
dc.contributor.googleauthorSeiji Niho-
dc.contributor.googleauthorGabriel Mak-
dc.contributor.googleauthorWenliang Yao-
dc.contributor.googleauthorNorah Shire-
dc.contributor.googleauthorHaiyi Jiang-
dc.contributor.googleauthorByoung Chul Cho-
dc.identifier.doi10.1016/j.cllc.2019.12.006-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ03603-
dc.identifier.eissn1938-0690-
dc.identifier.pmid31948903-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S1525730419303742-
dc.subject.keywordClinical study-
dc.subject.keywordCytotoxic T-lymphocyte–associated antigen-4-
dc.subject.keywordImmunotherapy-
dc.subject.keywordProgrammed cell death ligand-1-
dc.subject.keywordSCLC-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume21-
dc.citation.number2-
dc.citation.startPage84-
dc.citation.endPage88-
dc.identifier.bibliographicCitationCLINICAL LUNG CANCER, Vol.21(2) : 84-88, 2020-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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