2023 World Conference on Lung Cancer (Posters)-P2.16. Durvalumab+EP in Advanced Large-Cell Neuroendocrine Carcinoma of Lung (aLCNEC): a Pilot Phase II study

P2.16. Durvalumab+EP in Advanced Large-Cell Neuroendocrine Carcinoma of Lung (aLCNEC): a Pilot Phase II study - PDF(Abstract)

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This document provides information about a pilot phase II study called DurvalumabEP in patients with advanced large-cell neuroendocrine carcinoma of the lung (aLCNEC). Large-cell neuroendocrine carcinoma is a rare and aggressive type of lung cancer that shares some characteristics with small-cell lung cancer. Current treatment options for aLCNEC, such as platinumetoposide chemotherapy, have limited effectiveness and poor survival rates.<br /><br />The study aims to investigate the activity and safety of combining the immune checkpoint inhibitor durvalumab with chemotherapy as a first-line treatment for aLCNEC. The enrolled patients will receive durvalumab, etoposide, and either carboplatin or cisplatin for four cycles, followed by maintenance durvalumab. The primary objective of the study is progression-free survival (PFS) at 12 months, with secondary objectives including objective response rate (ORR), overall survival (OS) at 12 months, and safety profile. Exploratory objectives include analyzing tumor molecular subtype, tumor mutational burden, and PD-L1 tumor proportion score in correlation with ORR, PFS, and OS.<br /><br />The study is ongoing, with six patients enrolled so far. No new safety concerns have been reported. The primary hypothesis to be tested for PFS at 12 months is a 5% rate without treatment (H0) and an 18% rate with treatment (H1). The study is registered on ClinicalTrials.gov.<br /><br />This pilot phase II study is significant because it investigates a potential new treatment approach for aLCNEC, a rare and aggressive type of lung cancer. The combination of durvalumab with chemotherapy aims to improve outcomes for patients by targeting immune checkpoint pathways. The study will provide important data on the efficacy and safety of this treatment regimen, which may contribute to the development of more effective therapies for aLCNEC.

Asset Subtitle

Elizabeth Dudnik

Meta Tag

Speaker Elizabeth Dudnik

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

DurvalumabEP

pilot phase II study

advanced large-cell neuroendocrine carcinoma of the lung

aLCNEC

lung cancer

small-cell lung cancer

chemotherapy

immune checkpoint inhibitor

durvalumab

progression-free survival