Evidence map›Paper›PMID 40840233›Full record

Trial reportESMO open2025

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, M R García Campelo, J-B Paoli, D Kowalski, C Bennati, P Borghetti, D Cortinovis, A Delmonte, C Genova, S Van Hulst and 11 more

Abstract readClinical Trial, Phase IIControlled Clinical Trial
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

A R FilippiRadiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Electronic address: andreariccardo.filippi@istitutotumori.mi.it.
M R García CampeloMedical Oncology, University Hospital A Coruña, A Coruña, Spain.
J-B PaoliRadiotherapie, Hôpital Privé Clairval, Marseille, France.
D KowalskiDepartment of Lung Cancer and Thoracic Tumors, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
C BennatiOncology Unit, S Maria delle Croci Hospital, AUSL della Romagna, Ravenna, Italy.
P BorghettiRadiation Oncology Department, ASST Spedali Civili and University of Brescia, Brescia, Italy.
D CortinovisMedical Oncology Unit, Fondazione IRCCS San Gerardo dei Tintori Monza, Monza, Italy; Medicine and Surgery Department, Milano Bicocca University, Monza, Italy.
A DelmonteDepartment of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), Meldola, Italy.
C GenovaDepartment of Internal Medicine and Medical Specialties, University of Genoa, Genoa; Academic Oncology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
S Van HulstOncology, University Hospital of Nîmes, Nîmes, France.
R M MrozII Department of Lung Diseases, Lung Cancer and Internal Diseases, Medical University of Bialystok, Białystok.
S NawrockiDepartment of Oncology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.
I ToledanoOncology, CCGM, Clinique Clémentville, Montpellier, France.
G ToniniMedical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy; Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, Italy.
F AgustoniMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
G WetherillAstraZeneca, Cambridge, UK.
Z ZhuAstraZeneca, Gaithersburg, USA.
I D PerezAstraZeneca, Gaithersburg, USA.
K ForoutanpourAstraZeneca, Gaithersburg, USA.
N GeorgouliaAstraZeneca, Gaithersburg, USA.
R DziadziuszkoDepartment of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently, 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

methodsPatients 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.).

resultsAs 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.

conclusionsThe 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.

Indexed as

Antibodies, MonoclonalAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungLung NeoplasmsAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm StagingAntibodies, MonoclonalAntineoplastic Agents, Immunologicaldurvalumabdurvalumabfrailnon-small-cell lung cancerradiotherapyunresectable

Identifiers

PMID40840233
PMCPMC12529302

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.