2023 World Conference on Lung Cancer (Posters)-EP07.05. NEOEAST: A Phase II Study of Ensartinib as Neoadjuvant Therapy for Stage II-IIIB ALK-rearranged Non-small Cell Lung Cancer

EP07.05. NEOEAST: A Phase II Study of Ensartinib as Neoadjuvant Therapy for Stage II-IIIB ALK-rearranged Non-small Cell Lung Cancer - PDF(Abstract)

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This document is a summary of a scientific presentation titled "NEOEAST: A Phase II Study of Ensartinib as Neoadjuvant Therapy for Stage II-IIIB ALK-rearranged Non-small Cell Lung Cancer." The presentation was part of a session on early-stage non-small cell lung cancer (NSCLC) at the WCLC 2023 conference.<br /><br />The neoadjuvant approach, which involves treating cancer before surgery, can improve the curability of lung cancer. Several drugs called anaplastic lymphoma kinase (ALK) inhibitors have been shown to be effective in treating advanced ALK-rearranged NSCLC. However, their benefit as neoadjuvant therapy for early-stage NSCLC is not well understood.<br /><br />This study aims to evaluate the feasibility of using ensartinib, a new-generation ALK inhibitor, as neoadjuvant therapy for resectable stage II-IIIB ALK lung adenocarcinoma. The study is a phase II trial that is currently ongoing. Eligible patients must have confirmed ALK fusion and resectable lung adenocarcinoma.<br /><br />Enrolled patients will receive oral ensartinib once daily for 8 weeks as neoadjuvant therapy. After completion of neoadjuvant therapy, patients will undergo surgery within 3-21 days. Following surgery, patients may receive adjuvant therapy with platinum-containing chemotherapy and ensartinib based on their response and pathology.<br /><br />The primary endpoint of the study is major pathologic response, defined as no more than 10% residual viable tumor cells in the surgical specimen. Secondary endpoints include pathologic complete response, objective response rate, disease-free survival, overall survival, and safety.<br /><br />Enrollment for the study began in May 2022, and data collection is expected to be completed in 2024.<br /><br />In summary, this study aims to determine the efficacy and safety of ensartinib as neoadjuvant therapy for early-stage ALK-rearranged NSCLC.

Asset Subtitle

Fang-Liang Lu

Meta Tag

Speaker Fang-Liang Lu

Topic Early-Stage NSCLC: Pushing the Boundaries

Keywords

NEOEAST

Phase II Study

Ensartinib

Neoadjuvant Therapy

Stage II-IIIB

ALK-rearranged Non-small Cell Lung Cancer

Curability of Lung Cancer

Anaplastic Lymphoma Kinase Inhibitors

Resectable Lung Adenocarcinoma

Feasibility Study