Trial reportJNCI cancer spectrum2026
Sequential chemo-durvalumab, reduced-dose RT, and consolidation durvalumab for unresectable stage III NSCLC unfit for PACIFIC regimen (DEDALUS trial).
Trial report in JNCI cancer spectrum, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05128630 (An Open-label, Multi-center, Phase 2 Study of Chemo-immunotherapy Followed by Reduced-dose Hypo-fractionated RT and Maintenance Immunotherapy for Stage III Unresectable Non -Small-cell Lung Carcinoma), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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An Open-label, Multi-center, Phase 2 Study of Chemo-immunotherapy Followed by Reduced-dose Hypo-fractionated RT and Maintenance Immunotherapy for Stage III Unresectable Non -Small-cell Lung Carcinoma (NSCLC).
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Authors and funding
15 authors.
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Abstract
backgroundThe PACIFIC study established the standard of care for unresectable, stage III non-small cell lung cancer (NSCLC). The DEDALUS trial is a phase 2, open-label, multicenter study enrolling patients who are eligible for sequential chemo-radiation therapy (CRT) plus immunotherapy.
methodsPatients had unresectable stage IIIA-C NSCLC, regardless of PD-L1 status. After 3 cycles of chemo-durvalumab, responders received hypo-fractionated thoracic radiotherapy (45 Gy over 3 weeks) with durvalumab, then continued durvalumab for up to 12 months or until disease progression. Primary endpoint was safety, assessed by the incidence of grade 3 and 4 possibly related adverse events (PRAEs) within 6 months. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and quality of life (NCT05128630).
resultsBetween February 2022 and August 2024, 28 patients were screened, and 25 enrolled across 3 Italian centers. Enrollment was halted early due to low recruitment. We recorded 9 grade 3-4 PRAEs, which accounted for 6.4% of all AEs; 7 patients (28%) experienced at least 1 grade 3-4 PRAE. Only 1 was immune-related, while the remaining PRAEs were related to chemotherapy, none to RT. Median PFS was 13.2 months (95% CI = 4.9 to 18.6), median OS was 17.5 months (95% CI = 10.7 to 18.6). Among the 16 patients who started maintenance without progression median PFS was 18.6 months (95% CI = 12.8 to not reached), median OS was not reached.
conclusionsThe early closure of the study and the reduced sample size make it difficult to draw significant conclusions. However, feasibility and safety seem to be acceptable, and early PFS and OS data are promising, especially for patients who completed the full treatment sequence.
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