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. 2025 Aug 20;10(9):105560.
doi: 10.1016/j.esmoop.2025.105560. Online ahead of print.

Durvalumab after radiotherapy in patients with unresectable stage III non-small-cell lung cancer ineligible for chemotherapy: the DUART phase II nonrandomized controlled study

A R Filippi  1 , M R García Campelo  2 , J-B Paoli  3 , D Kowalski  4 , C Bennati  5 , P Borghetti  6 , D Cortinovis  7 , A Delmonte  8 , C Genova  9 , S Van Hulst  10 , R M Mroz  11 , S Nawrocki  12 , I Toledano  13 , G Tonini  14 , F Agustoni  15 , G Wetherill  16 , Z Zhu  17 , I D Perez  17 , K Foroutanpour  17 , N Georgoulia  17 , R Dziadziuszko  18
Affiliations
Free article

Durvalumab after radiotherapy in patients with unresectable stage III non-small-cell lung cancer ineligible for chemotherapy: the DUART phase II nonrandomized controlled study

A R Filippi et al. ESMO Open. .
Free article

Abstract

Background: Currently, patients with unresectable stage III non-small-cell lung cancer (NSCLC) ineligible for chemotherapy receive radiotherapy alone, with unsatisfactory results. DUART was a phase II single-arm trial of durvalumab in patients without progression after radiotherapy for unresectable stage III NSCLC.

Patients and methods: Patients were enrolled into parallel cohorts per radiotherapy dose (A: definitive; B: palliative) and received durvalumab (1500 mg every 4 weeks for up to 12 months). The primary endpoint was incidence of grade 3/4 possibly related adverse events (PRAEs) within 6 months of durvalumab initiation. Secondary endpoints included objective response rate, progression-free survival (PFS), and overall survival (OS). Exploratory circulating tumor (ctDNA) analyses utilized a targeted methylation assay (GRAIL, Inc.).

Results: As of 06 December 2023, 102 patients received durvalumab (cohort A: 53; cohort B: 49); 18.8%/73.3%/7.9% had Eastern Cooperative Oncology Group performance status 0/1/2 and median age was 79.0 years. Overall, 9.8% [95% confidence interval (CI) 4.8% to 17.3%] had grade 3/4 PRAEs within 6 months of durvalumab initiation. Median PFS (investigator assessed) was 9.2 months, with a 12-month landmark rate of 39.6%. Median OS was 21.1 months and the 12-month landmark rate was 64.7%. Patients who were ctDNA positive at cycle 1 or 7 had shorter PFS versus patients who were ctDNA negative at the same time point.

Conclusions: The safety profile of durvalumab after radiotherapy was consistent with PACIFIC (durvalumab after chemoradiotherapy). Efficacy across cohorts was encouraging. Some patients may achieve or maintain molecular remission with durvalumab even after palliative radiotherapy. Durvalumab following radiotherapy may be a potential treatment option in a frailer, older, chemotherapy-ineligible population.

Keywords: durvalumab; frail; non-small-cell lung cancer; radiotherapy; unresectable.

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Conflict of interest statement

Disclosure ARF reports receipt of honoraria from AstraZeneca, Roche, and Takeda; consulting fee(s) from AstraZeneca and Radiomics.bio; grants or research funds from AstraZeneca, Roche, Merck Sharp & Dohme, and Radiomics.bio; and reports other potential financial relationships (e.g. holding a patent or receiving royalties, travel grants, lecture fees, etc.) with AstraZeneca and Elekta. MRGC reports receipt of honoraria and consulting fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Roche, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, Sanofi, and Takeda. JBP reports other potential financial relationships (e.g. holding a patent or receiving royalties, travel grants, lecture fees, etc.) with AstraZeneca, Merck Sharp & Dohme, Pfizer, Ipsen, Roche, Sanofi, Janssen-Cilag, Boehringer Ingelheim, BMSi, and Amgen. DK reports receipt of honoraria and consulting fees from Amgen, AstraZeneca, Bristol Myers Squibb, Roche, Johnson & Johnson, Merck Sharp & Dohme, Pfizer, Sanofi, Takeda, and BeiGene. CB reports consulting fees from AstraZeneca, Bristol Myers Squibb, Roche, Janssen, Merck Sharp & Dohme, and Pfizer. PB reports receipt of consulting fees from AstraZeneca, Roche, Amgen, and Takeda; and grants or research funds from Roche. DC reports receipt of consulting fees from Bristol Myers Squibb, Merck Sharp & Dohme, AstraZeneca, Pfizer, Boehringer Ingelheim, Roche, Novartis, Amgen, BeiGene, and Johnson & Johnson. AD reports receipt of consulting fees from AstraZeneca, Takeda, and Novartis; providing paid expert testimony for Bristol Myers Squibb; and receipt of travel grants from Roche, Merck Sharp & Dohme, Takeda, and Pfizer. CG reports receipt of honoraria from AstraZeneca, Bristol Myers Squibb, Lilly, Merck Sharp & Dohme, Novartis, Pierre Fabre, Regeneron, and Takeda; and grants or research funds from the Italian Ministry of Health and FONICAP-LILT. RMM reports receipt of honoraria and consulting fees from Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, Gilead, GlaxoSmithKline, Novartis, Pearl Pharmaceuticals, Merck Sharp & Dohme, Roche, Sanofi, Takeda, and Teva. GT reports receipt of consulting fees from PharmaMar, Merck Sharp & Dohme, Molteni, and Novartis. FA reports other potential financial relationships (e.g. holding a patent or receiving royalties, travel grants, lecture fees, etc.) with AstraZeneca, Roche, Merck Sharp & Dohme, Regeneron, Takeda, Sanofi, and Bristol Myers Squibb. GW reports consulting fees for work as a consultant statistician for AstraZeneca. ZZ reports employment with AstraZeneca and ownership of stock/shares in AstraZeneca and Pfizer. IDP and NG report employment with and ownership of stock/shares in AstraZeneca. KF reports receipt of consulting fees from AstraZeneca. RD reports participation in advisory council(s) or committee(s) for AstraZeneca, Roche, Boehringer Ingelheim, Merck Sharp & Dohme, Janssen, GlaxoSmithKline, Bristol Myers Squibb, and Pfizer; receipt of consulting fees from OSE Immunotherapeutics; grants or research funds from Merck Sharp & Dohme, Roche, and AstraZeneca; and receipt of drug samples from Novartis and Pfizer. All other authors have declared no conflicts of interest.

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