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

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A pilot phase II study is being conducted to evaluate the effectiveness of durvalumabEP combination therapy as a first-line treatment for advanced large-cell neuroendocrine carcinoma of the lung (aLCNEC). Currently, treatment options for aLCNEC are limited, and while platinumetoposide (EP) chemotherapy regimens are used, the responses are short-lived and survival rates are poor. The study aims to assess the progression-free survival (PFS) at 12 months as the primary objective, as well as objective response rate (ORR), overall survival (OS) at 12 months, and safety profile as secondary objectives.<br /><br />The enrolled patients will receive intravenous durvalumab and etoposide for four cycles, followed by maintenance durvalumab. The treatment will continue until progression of the disease, unacceptable toxicity, or 24 months after treatment initiation. The study is ongoing, with 7 subjects currently enrolled, and no new safety signals have been observed.<br /><br />The study is registered on the clinicaltrials.gov portal, with a sample size of 22 eligible patients. The main inclusion criteria include advanced-stage LCNEC without prior systemic treatment, measurable disease, good performance status, and normal organ function. The main exclusion criteria include a history of carcinomatous meningitis, prior treatment with anti-PD-1/anti-PD-L1 agents or chemotherapy, use of immunosuppressive medications, and certain medical conditions.<br /><br />This is a prospective, non-randomized, non-comparative, open-label, single-center pilot study. It aims to explore the activity and safety of the durvalumabEP combination as a first-line therapy for treatment-naïve aLCNEC. The study is funded by AstraZeneca as an Investigator Initiated Study granted to Assuta Medical Centers.<br /><br />Overall, the pilot phase II study seeks to evaluate the efficacy and safety of the durvalumabEP combination as a potential first-line treatment option for aLCNEC. The results of the study will provide valuable insights into the clinical activity of immune checkpoint inhibitors in aLCNEC and may contribute to improving treatment outcomes for patients with this rare and challenging form of lung cancer.

Asset Subtitle

Elizabeth Dudnik

Meta Tag

Speaker Elizabeth Dudnik

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

pilot phase II study

durvalumabEP combination therapy

first-line treatment

advanced large-cell neuroendocrine carcinoma of the lung

aLCNEC

platinumetoposide chemotherapy regimens

progression-free survival

objective response rate

overall survival

safety profile