2022 World Conference on Lung Cancer (ePosters)-EP14.01-020. Trial in Progress: [177Lu]Lu-DOTA-TATE Combination Therapy in Treatment-Naïve Extensive Stage Small Cell Lung Cancer

EP14.01-020. Trial in Progress: [177Lu]Lu-DOTA-TATE Combination Therapy in Treatment-Naïve Extensive Stage Small Cell Lung Cancer

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This document is an abstract of a clinical study that aims to evaluate the safety and effectiveness of a combination therapy for newly diagnosed patients with extensive stage small cell lung cancer (ES-SCLC). The study focuses on the use of [177Lu]Lu-DOTA-TATE, a radioligand therapy that targets somatostatin receptors, in combination with standard chemotherapy drugs (carboplatin, etoposide) and the programmed death-ligand 1 inhibitor, tislelizumab.<br /><br />The study design consists of a screening period, a treatment period (including an induction treatment period and a maintenance treatment period), and a follow-up period. Participants will be enrolled in cohorts of 3 to 6 participants and will receive four cycles of carboplatin and etoposide during the induction period, tislelizumab every 3 weeks during both the induction and maintenance periods, and multiple administrations of [177Lu]Lu-DOTA-TATE during both the induction and maintenance periods.<br /><br />The primary objective of the study is to establish the recommended dose of [177Lu]Lu-DOTA-TATE in combination with the other drugs for the treatment of ES-SCLC. Secondary objectives include assessing the safety, tolerability, and anti-tumor activity of the combination therapy, as well as evaluating the pharmacokinetics of [177Lu]Lu-DOTA-TATE and tislelizumab.<br /><br />The study population will include approximately 39 female and male participants with newly diagnosed ES-SCLC. Participants must have measurable disease and be positive for somatostatin receptors according to imaging scans. Key inclusion and exclusion criteria are provided.<br /><br />The study aims to provide a potential novel therapeutic option for patients with ES-SCLC, which currently has limited therapeutic options and poor prognosis. The study is sponsored by AAA, a Novartis company.<br /><br />In summary, this clinical study will evaluate the combination of [177Lu]Lu-DOTA-TATE with carboplatin, etoposide, and tislelizumab as a first-line treatment for newly diagnosed ES-SCLC. The study aims to determine the recommended dose, assess safety and anti-tumor activity, and provide a potential new treatment option for patients with this aggressive cancer type.

Asset Subtitle

Stephen V. Liu

Meta Tag

Speaker Stephen V. Liu

Topic Small Cell Lung Cancer and Neuro-endocrine Tumours - Informing ES-SCLC

Keywords

clinical study

combination therapy

ES-SCLC

[177Lu]Lu-DOTA-TATE

somatostatin receptors

carboplatin

etoposide

tislelizumab

recommended dose

anti-tumor activity