Cited 35 times in
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
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2020-04-13T16:58:12Z | - |
dc.date.available | 2020-04-13T16:58:12Z | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 1525-7304 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/175586 | - |
dc.description.abstract | Limited-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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | CLINICAL LUNG CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Suresh Senan | - |
dc.contributor.googleauthor | Isamu Okamoto | - |
dc.contributor.googleauthor | Gyeong-won Lee | - |
dc.contributor.googleauthor | Yuanbin Chen | - |
dc.contributor.googleauthor | Seiji Niho | - |
dc.contributor.googleauthor | Gabriel Mak | - |
dc.contributor.googleauthor | Wenliang Yao | - |
dc.contributor.googleauthor | Norah Shire | - |
dc.contributor.googleauthor | Haiyi Jiang | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.identifier.doi | 10.1016/j.cllc.2019.12.006 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J03603 | - |
dc.identifier.eissn | 1938-0690 | - |
dc.identifier.pmid | 31948903 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S1525730419303742 | - |
dc.subject.keyword | Clinical study | - |
dc.subject.keyword | Cytotoxic T-lymphocyte–associated antigen-4 | - |
dc.subject.keyword | Immunotherapy | - |
dc.subject.keyword | Programmed cell death ligand-1 | - |
dc.subject.keyword | SCLC | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 21 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 84 | - |
dc.citation.endPage | 88 | - |
dc.identifier.bibliographicCitation | CLINICAL LUNG CANCER, Vol.21(2) : 84-88, 2020 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.