Abstract 198TiP
Background
PACIFIC regimen is the gold standard for patients with unresectable locally advanced Non-Small Cell Lung Cancer (NSCLC). Moving forward on developing the best treatment combination, this study aims to assess the safety and efficacy of a regimen of induction chemo-immunotherapy followed by de-intensified, hypo-fractionated RT given concurrently with Durvalumab followed by Durvalumab maintenance in patients with unresectable, stage III NSCLC.
Trial Design
Dedalus trial is a phase 2, open-label, single-arm, multi-center, Italian study designed to determine safety of chemo-immunotherapy followed by reduced-dose hypo-fractionated radiotherapy and maintenance immunotherapy with a fixed dose of Durvalumab monotherapy. 45 patients will be enrolled from March 2022 to March 2024. Patients will meet the following major criteria could be included: NSCLC stage III, PD-L1 all comers, judged unresectable and ineligible for cCRT by thoracic multidisciplinary board and then candidate to sCRT. After three cycles of Cisplatin/Carboplatin (AUC5) plus Etoposide plus Durvalumab every three weeks, responders will be receiving hypo-fractionated thoracic RT (45 Gy over 3 weeks) plus Durvalumab, followed by Durvalumab maintenance up to 12 months or progression. Primary endpoint is safety, defined by the incidence of grade 3-4 possibly related adverse events within 6 months from the initiation of treatment. Secondary objectives are PFS and OS (median and 12 months) and quality of life (investigated through EORTC QLQ-C30 and LC13 questionnaires). Ancillary studies consist of radiomic and molecular analyses: correlation of radiomic signatures extracted form baseline and post-RT TC-scans with PFS; molecular alterations detected on tumor tissue specimens obtained at diagnosis will be monitored on ctDNA in plasma specimens trough liquid biopsies at 3 different time-points (at baseline, after radiotherapy and at progression). First patient was enrolled in March 2022; at the time of submission, eight patients are included in the trial.
Clinical trial identification
NCT05128630.
Legal entity responsible for the study
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Funding
AstraZeneca.
Disclosure
All authors have declared no conflicts of interest.