{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1363388843924512256.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1016/s1470-2045(10)70132-7"}},{"identifier":{"@type":"URI","@value":"https://api.elsevier.com/content/article/PII:S1470204510701327?httpAccept=text/xml"}},{"identifier":{"@type":"URI","@value":"https://api.elsevier.com/content/article/PII:S1470204510701327?httpAccept=text/plain"}},{"identifier":{"@type":"PMID","@value":"20610317"}}],"dc:title":[{"@value":"Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial"}],"description":[{"notation":[{"@value":"Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) tyrosine kinases. In a randomised phase 2 study in patients with previously treated non-small-cell lung cancer (NSCLC), adding vandetanib 100 mg to docetaxel significantly improved progression-free survival (PFS) compared with docetaxel alone, including a longer PFS in women. These results supported investigation of the combination in this larger, definitive phase 3 trial (ZODIAC).Between May, 2006, and April, 2008, patients with locally advanced or metastatic (stage IIIB-IV) NSCLC after progression following first-line chemotherapy were randomly assigned 1:1 through a third-party interactive voice system to receive vandetanib (100 mg/day) plus docetaxel (75 mg/m(2) intravenously every 21 days; maximum six cycles) or placebo plus docetaxel. The primary objective was comparison of PFS between the two groups in the intention-to-treat population. Women were a coprimary analysis population. This study has been completed and is registered with ClinicalTrials.gov, number NCT00312377.1391 patients received vandetanib plus docetaxel (n=694 [197 women]) or placebo plus docetaxel (n=697 [224 women]). Vandetanib plus docetaxel led to a significant improvement in PFS versus placebo plus docetaxel (hazard ratio [HR] 0.79, 97.58% CI 0.70-0.90; p0.0001); median PFS was 4.0 months in the vandetanib group versus 3.2 months in placebo group. A similar improvement in PFS with vandetanib plus docetaxel versus placebo plus docetaxel was seen in women (HR 0.79, 0.62-1.00, p=0.024); median PFS was 4.6 months in the vandetanib group versus 4.2 months in the placebo group. Among grade 3 or higher adverse events, rash (63/689 [9%] vs 7/690 [1%]), neutropenia (199/689 [29%] vs 164/690 [24%]), leukopenia (99/689 [14%] vs 77/690 [11%]), and febrile neutropenia (61/689 [9%] vs 48/690 [7%]) were more common with vandetanib plus docetaxel than with placebo plus docetaxel. The most common serious adverse event was febrile neutropenia (46/689 [7%] in the vandetanib group vs 38/690 [6%] in the placebo group).The addition of vandetanib to docetaxel provides a significant improvement in PFS in patients with advanced NSCLC after progression following first-line therapy."}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1383388843924512271","@type":"Researcher","foaf:name":[{"@value":"Roy S Herbst"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512259","@type":"Researcher","foaf:name":[{"@value":"Yan Sun"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512265","@type":"Researcher","foaf:name":[{"@value":"Wilfried EE Eberhardt"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512268","@type":"Researcher","foaf:name":[{"@value":"Paul Germonpré"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512256","@type":"Researcher","foaf:name":[{"@value":"Nagahiro Saijo"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512385","@type":"Researcher","foaf:name":[{"@value":"Caicun Zhou"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512269","@type":"Researcher","foaf:name":[{"@value":"Jie Wang"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512261","@type":"Researcher","foaf:name":[{"@value":"Longyun Li"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512263","@type":"Researcher","foaf:name":[{"@value":"Fairooz Kabbinavar"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512266","@type":"Researcher","foaf:name":[{"@value":"Yukito Ichinose"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512262","@type":"Researcher","foaf:name":[{"@value":"Shukui Qin"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512264","@type":"Researcher","foaf:name":[{"@value":"Li Zhang"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512260","@type":"Researcher","foaf:name":[{"@value":"Bonne Biesma"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512384","@type":"Researcher","foaf:name":[{"@value":"John V Heymach"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512267","@type":"Researcher","foaf:name":[{"@value":"Peter Langmuir"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512270","@type":"Researcher","foaf:name":[{"@value":"Sarah J Kennedy"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512258","@type":"Researcher","foaf:name":[{"@value":"Hiroomi Tada"}]},{"@id":"https://cir.nii.ac.jp/crid/1383388843924512257","@type":"Researcher","foaf:name":[{"@value":"Bruce E Johnson"}]}],"publication":{"publicationIdentifier":[{"@type":"PISSN","@value":"14702045"}],"prism:publicationName":[{"@value":"The Lancet Oncology"}],"dc:publisher":[{"@value":"Elsevier BV"}],"prism:publicationDate":"2010-07","prism:volume":"11","prism:number":"7","prism:startingPage":"619","prism:endingPage":"626"},"reviewed":"false","dcterms:accessRights":"http://purl.org/coar/access_right/c_abf2","dc:rights":["https://www.elsevier.com/tdm/userlicense/1.0/","https://www.elsevier.com/legal/tdmrep-license"],"url":[{"@id":"https://api.elsevier.com/content/article/PII:S1470204510701327?httpAccept=text/xml"},{"@id":"https://api.elsevier.com/content/article/PII:S1470204510701327?httpAccept=text/plain"}],"createdAt":"2010-06-08","modifiedAt":"2025-10-26","foaf:topic":[{"@id":"https://cir.nii.ac.jp/all?q=Adult","dc:title":"Adult"},{"@id":"https://cir.nii.ac.jp/all?q=Aged,%2080%20and%20over","dc:title":"Aged, 80 and over"},{"@id":"https://cir.nii.ac.jp/all?q=Male","dc:title":"Male"},{"@id":"https://cir.nii.ac.jp/all?q=Lung%20Neoplasms","dc:title":"Lung 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