PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy

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dc.contributor.authorWu, Yi-Long
dc.contributor.authorWu, Lin
dc.contributor.authorBi, Nan
dc.contributor.authorCil, Timucin
dc.contributor.authorGe, Hong
dc.contributor.authorZhu, Zhengfei
dc.contributor.authorWang, Chih-Liang
dc.date.accessioned2026-04-04T13:33:06Z
dc.date.available2026-04-04T13:33:06Z
dc.date.issued2025
dc.departmentİnönü Üniversitesi
dc.description.abstractBackgroundConsolidation durvalumab following no progression on concurrent chemoradiotherapy (cCRT) is standard of care for unresectable stage III non-small-cell lung cancer (NSCLC). However, in clinical practice many patients receive sequential CRT (sCRT). The PACIFIC-5 trial aimed to evaluate the efficacy and safety of consolidation durvalumab for unresectable stage III NSCLC following no progression on cCRT or sCRT.MethodsThis randomised, double-blind, placebo-controlled, phase III trial enrolled patients aged >= 18 years with unresectable stage III NSCLC, regardless of PD-L1 expression or sensitising EGFR or ALK aberrations, without disease progression after cCRT or sCRT. Patients were randomised (2:1) to durvalumab 1500 mg or placebo intravenously every 4 weeks (stratified by tumour PD-L1 expression and prior treatment) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was progression-free survival (PFS) by blinded independent central review in the modified intention-to-treat population (mITT). Secondary endpoints included overall survival (OS) in the mITT and safety. The safety analysis set include patients who received at least one dose of study treatment.ResultsOf 407 patients randomised to receive durvalumab (n = 272) or placebo (n = 135), 405 received at least one dose of durvalumab (n = 271) or placebo (n = 134). The mITT comprised 381 patients randomised to durvalumab (n = 252) or placebo (n = 129). Durvalumab showed statistically significant improvement in PFS versus placebo in the mITT (median [95% confidence interval {CI}], 14.0 [10.9-18.0] vs. 6.5 [5.4-13.8] months; hazard ratio [95% CI], 0.75 [0.58-0.99]; p = 0.038). There was a trend toward improved OS with durvalumab versus placebo in the mITT (median [95% CI], 38.3 [28.9-42.8] vs. 32.5 [20.6-40.4] months; hazard ratio [95% CI], 0.87 [0.66-1.17]; p = 0.346 [interim analysis]). Among the safety analysis set, maximum grade 3 or 4 adverse events of any cause occurred in 26.9% (73/271) and 23.9% (32/134) and 1.5% (4/271) and 0% (0/134) had treatment-related adverse events leading to death for durvalumab and placebo, respectively.ConclusionsPACIFIC-5 met its primary endpoint of improved PFS after either cCRT or sCRT. Follow-up for overall survival is ongoing.Trial registrationNCT03706690.
dc.description.sponsorshipAstraZeneca
dc.description.sponsorshipThis study was funded by AstraZeneca; clinicalTrials.gov number, NCT03706690.
dc.identifier.doi10.1186/s13045-025-01768-1
dc.identifier.issn1756-8722
dc.identifier.issue1
dc.identifier.orcid0000-0003-3324-0900
dc.identifier.orcid0000-0002-3611-0258
dc.identifier.orcid0000-0001-7078-7767
dc.identifier.pmid41354932
dc.identifier.scopus2-s2.0-105024344492
dc.identifier.scopusqualityQ1
dc.identifier.urihttps://doi.org/10.1186/s13045-025-01768-1
dc.identifier.urihttps://hdl.handle.net/11616/108927
dc.identifier.volume18
dc.identifier.wosWOS:001634547800001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoen
dc.publisherBmc
dc.relation.ispartofJournal of Hematology & Oncology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.snmzKA_WOS_20250329
dc.subjectNon-small-cell lung cancer
dc.subjectImmunotherapy
dc.subjectChemoradiotherapy
dc.subjectClinical trial
dc.subjectPhase III
dc.subjectDurvalumab
dc.titlePACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy
dc.typeArticle

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