2024 World Conference on Lung Cancer (WCLC) - Posters-P1.13A.03 MOZART: Phase II Trial of Monalizumab, Durvalumab, and Platinum-based Chemotherapy for First-Line Treatment of Extensive Stage SCLC

P1.13A.03 MOZART: Phase II Trial of Monalizumab, Durvalumab, and Platinum-based Chemotherapy for First-Line Treatment of Extensive Stage SCLC

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The MOZART trial is a phase II clinical study investigating the combination of Monalizumab, Durvalumab, and platinum-based chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC). The study is conducted by several institutions across the United States, including the Barbara Ann Karmanos Cancer Institute, the University of Virginia, the University of Iowa, and Indiana University.<br /><br />The trial focuses on patients who have not previously been treated for extensive-stage SCLC but may have received up to one cycle of platinum doublet chemotherapy, with or without Durvalumab, within four weeks prior to joining the study. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and may have treated or untreated asymptomatic brain metastases, provided they are stable and not requiring systemic steroids for at least a week.<br /><br />The study examines the potential enhancement of anti-tumor immunity through the blockade of NKG2A/CD94, an inhibitory receptor expressed on NK and CD8 T cells. The inhibition of NKG2A is hypothesized to bolster the anti-tumor effects of NK and CD8 T cells, especially in combination with PD-(L)1 blocking agents.<br /><br />Key objectives include determining the 1-year progression-free survival rate and assessing the incidence and severity of treatment-related adverse events. Secondary objectives focus on evaluating the objective response rate, 1-year overall survival, and intracranial progression-free survival. The study also explores associations with immune cell activity, blood and tissue-based gene expression, mutation, and methylation profiles, as well as changes in circulating tumor-derived material such as ctDNA and ctRNA.<br /><br />The trial aims to improve the standard of care, which currently offers a median overall survival of just over one year, by enhancing immune response mechanisms against SCLC.

Asset Subtitle

Hirva Mamdani

Meta Tag

Speaker Hirva Mamdani

Topic SCLC & Neuroendocrine Tumors

Keywords

MOZART trial

Monalizumab

Durvalumab

platinum-based chemotherapy

extensive-stage small-cell lung cancer

NKG2A/CD94 blockade

anti-tumor immunity

progression-free survival

treatment-related adverse events

immune response mechanisms