Abstract
Introduction/Background
This single-arm, phase 2, multi-center, study aims to assess the safety and efficacy
of a regimen of induction chemo-immunotherapy followed by de-intensified, hypo-fractionated
thoracic radiotherapy (RT) given concurrently with durvalumab and maintenance durvalumab
in patients with unresectable, stage III NSCLC.
Material and methods
we will enroll 45 patients with unresectable stage III NSCLC, any PD-L1, deemed ineligible
for concurrent CRT by a thoracic oncology multidisciplinary team, and candidate to
sequential chemoradiation followed by durvalumab.
Results
Primary endpoint is safety, defined by the incidence of grade 3 and 4 possibly related
adverse events (PRAEs) within 6 months from the initiation of treatment. The secondary
objectives are PFS and OS (median and 12 months). Ancillary endpoints are molecular
response evaluated by cfDNA isolation baseline, after chemo-immuno RT and at progression,
and radiomics analysis on CT scans at baseline and before maintenance.
Conclusion
DEDALUS phase 2 trial explores the safety and efficacy of a novel sequence of chemo-radiation
(with de-intensified RT) plus the anti-PD-L1 agent durvalumab in patients with stage
III unresectable NSCLC who are candidates to sequential chemoradiation plus maintenance
immunotherapy.
Keywords
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Article info
Publication history
Published online: January 20, 2023
Accepted:
December 23,
2022
Received:
September 24,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
