2022 World Conference on Lung Cancer (ePosters)-EP02.04-001. Alectinib as Neoadjuvant Treatment in Surgically Resectable Stage III ALK-Positive NSCLC: ALNEO Phase II Trial (GOIRC-01-2020)

EP02.04-001. Alectinib as Neoadjuvant Treatment in Surgically Resectable Stage III ALK-Positive NSCLC: ALNEO Phase II Trial (GOIRC-01-2020)

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The ALNEO Phase II trial, conducted by the Gruppo Oncologico Italiano di Ricerca Clinica, aims to investigate the use of alectinib as neoadjuvant treatment in surgically resectable stage III ALK-positive non-small cell lung cancer (NSCLC) patients. The primary endpoint of the study is major pathological response (MPR), which is defined as fewer than 10% of residual viable tumor cells in the resected primary tumor and lymph nodes. Secondary endpoints include pathological complete response (pCR), objective response (OR), event-free survival (EFS), disease-free survival (DFS), overall survival (OS), and the incidence of adverse events (AEs).<br /><br />Eligible patients for the study must have locally advanced stage III ALK-positive treatment-naive NSCLC that is potentially resectable. They must also have measurable disease and no evidence of metastatic disease. Patients will receive neoadjuvant oral alectinib for two cycles of four weeks each, followed by surgery with radical intent. After surgery, patients will receive adjuvant alectinib for 24 cycles.<br /><br />The study will follow a Simon's two-stage mini-max design, with the null hypothesis being an MPR rate of 20%. The study will be stopped early if there are four or fewer MPR in the first 18 patients. Otherwise, 15 additional patients will be enrolled for a total of 33. The null hypothesis will be rejected if 11 or more MPR are observed in the 33 patients.<br /><br />The ALNEO trial began in May 2021 and is planned to recruit 33 subjects from 20 national Italian centers. As of now, 13 patients have been accrued, and patient accrual will end in May 2023. The study is expected to close in May 2026.<br /><br />This study is supported by Roche and is registered on ClinicalTrials.gov with the identifier NCT05015010. The study aims to contribute to the understanding of the effectiveness of neoadjuvant alectinib in surgically resectable stage III ALK-positive NSCLC.

Asset Subtitle

Alessandro Leonetti

Meta Tag

Speaker Alessandro Leonetti

Topic Early Stage Non-small Cell Lung Cancer - Systemic Therapy

Keywords

ALNEO Phase II trial

alectinib

neoadjuvant treatment

surgically resectable

stage III ALK-positive NSCLC

major pathological response

pathological complete response

event-free survival

overall survival

ClinicalTrials.gov