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(Slides)

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A new study called NEOEAST is being conducted to evaluate the feasibility of using the ALK inhibitor ensartinib as neoadjuvant therapy for resectable, stage II-IIIB ALK-rearranged non-small cell lung cancer (NSCLC). ALK-rearranged NSCLC is the second most common subset of targetable oncogenic alterations in NSCLC. Previous retrospective data has shown that neoadjuvant ALK inhibitors are well-tolerated and can lead to a meaningful pathological response in early-stage NSCLC, but prospective evidence is still lacking. <br /><br />Ensartinib is a new-generation ALK inhibitor that has demonstrated efficacy in patients with advanced ALK NSCLC, with a progression-free survival of 31.3 months in overall patients and 41.5 months in Asian patients. It has been approved for use in advanced ALK NSCLC in the first-/second-line setting. The study aims to assess the major pathologic response (MPR) as the primary endpoint, defined as no more than 10% residual viable tumor cells in the surgical specimen. Secondary endpoints include pathologic complete response (pCR), objective response rate (ORR), disease-free survival, and overall survival.<br /><br />The study follows an open-label, single-arm, prospective, phase II design. Patients aged 18 to 75 years with resectable, stage II-IIIB ALK lung adenocarcinoma will receive ensartinib as neoadjuvant therapy for 8 weeks. Surgical resection will be scheduled within 3-21 days after the final dose of neoadjuvant therapy. After surgery, patients may receive adjuvant therapy with platinum-containing chemotherapy followed by up to 2 years of ensartinib. The study will evaluate the feasibility, safety, and efficacy of this treatment approach.<br /><br />Enrollment for the study has started in May 2022, and approximately 10 participants will be enrolled. Primary data collection is expected to be completed in 2024. The study is supported by Betta Pharmaceuticals Co., Ltd. The authors of the study express their gratitude to all participants and study centers. There are no conflicts of interest declared by the presenter.

Asset Subtitle

Fang-Liang Lu

Meta Tag

Speaker Fang-Liang Lu

Topic Early-Stage NSCLC: Pushing the Boundaries

Keywords

NEOEAST

ALK inhibitor

ensartinib

neoadjuvant therapy

resectable

stage II-IIIB

ALK-rearranged non-small cell lung cancer

NSCLC

pathological response

prospective evidence