2022 World Conference on Lung Cancer (ePosters)-EP05.01-025. Planned Interim Analysis of a Phase II Trial of Concurrent Durvalumab and Radiation Therapy for Locally Advanced Lung Cancer

EP05.01-025. Planned Interim Analysis of a Phase II Trial of Concurrent Durvalumab and Radiation Therapy for Locally Advanced Lung Cancer

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Researchers conducted a pre-planned interim analysis of a phase II trial investigating the safety and outcomes of combining durvalumab, an immunotherapy, with radiation therapy (RT) in patients with locally advanced lung cancer who are not eligible for concurrent chemoradiotherapy (cCRT). The study included 27 patients and focused on evaluating the efficacy of this treatment approach.<br /><br />Inclusion criteria for the study were as follows: patients with locally-advanced non-small cell lung cancer (NSCLC) at stage II-III, who were ineligible for concurrent chemoradiotherapy, and had unselected PD-L1 expression status. The patients were treated with durvalumab administered intravenously every four weeks and thoracic radiation therapy delivered at a dose of 54-66 Gy in 27-33 fractions. The primary endpoint of the study was progression-free survival (PFS) at 2 years, with secondary endpoints including overall survival (OS), objective response rate (ORR), and toxicity assessment.<br /><br />The analysis showed that preliminary PFS and OS outcomes were superior to historical results of sequential chemoradiotherapy or radiation therapy alone. The researchers did not encounter any early stopping safety rules. However, one patient experienced grade 5 pneumonitis, which is a severe adverse event related to treatment.<br /><br />This study is the first report on the concurrent administration of durvalumab and radiation therapy without chemotherapy in an elderly and frail population with locally advanced NSCLC. The outcomes suggest potential benefits in terms of PFS and OS compared to other treatment approaches. The researchers concluded that this study was an independent, investigator-initiated project supported by AstraZeneca, and its results contribute to understanding the use of immunotherapy and radiation therapy in this patient population. Clinicaltrials.gov identifier for the study is NCT03999710.

Asset Subtitle

Andreas Rimner

Meta Tag

Speaker Andreas Rimner

Topic Locally Advanced Non-small Cell Lung Cancer - Chemoradiotherapy and Radiotherapy

Keywords

phase II trial

durvalumab

immunotherapy

radiation therapy

locally advanced lung cancer

concurrent chemoradiotherapy

non-small cell lung cancer

PD-L1 expression

progression-free survival

overall survival