2022 World Conference on Lung Cancer (ePosters)-EP05.02-016. Aumolertinib after Adjuvant Chemotherapy/Radiotherapy in Stage pIIIA-N2 Non-Small-Cell Lung Cancer with EGFR Mutation

EP05.02-016. Aumolertinib after Adjuvant Chemotherapy/Radiotherapy in Stage pIIIA-N2 Non-Small-Cell Lung Cancer with EGFR Mutation

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The study aims to investigate the efficacy of aumolertinib as a maintenance therapy after adjuvant chemotherapy/radiotherapy for stage pIIIA-N2 non-small cell lung cancer (NSCLC) patients with EGFR mutation. Previous trials have shown that EGFR-TKIs improve disease-free survival (DFS) with fewer adverse events compared to chemotherapy. Adjuvant chemotherapy is the standard treatment for stage III NSCLC, providing a statistically significant overall survival (OS) benefit. Adjuvant radiotherapy has also been shown to improve local control rate and survival rate in pIIIA-N2 NSCLC. Aumolertinib is a novel 3rd generation EGFR-TKI that targets both EGFR-sensitizing and T790M resistance mutations, with promising efficacy and safety results in patients with resected stage - NSCLC harboring EGFR mutations. <br /><br />The study design is a double-blind, randomized, placebo-controlled trial. The primary endpoint is the DFS rate at 2 years, while key secondary endpoints include DFS, OS, and safety. Patients eligible for the study must be aged 18 years or older, have stage IIIA-N2 NSCLC with complete resection, and EGFR mutations (Ex19del/L858R), among other inclusion criteria. Patients with prior anti-EGFR-TKI therapy or pre-operative chemotherapy/radiotherapy are excluded. The study will assess the efficacy of aumolertinib compared to placebo in terms of DFS rate at 2 years and other endpoints such as DFS, OS, and safety. <br /><br />The study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. and aims to determine whether aumolertinib as a maintenance therapy can improve outcomes for stage pIIIA-N2 NSCLC patients with EGFR mutation after adjuvant chemotherapy/radiotherapy. This study will contribute to the understanding of the role of targeted therapy in this specific population.

Asset Subtitle

Yu Zhang

Meta Tag

Speaker Yu Zhang

Topic Locally Advanced Non-small Cell Lung Cancer - Neoadjuvant and Adjuvant Therapy

Keywords

aumolertinib

maintenance therapy

adjuvant chemotherapy

adjuvant radiotherapy

stage pIIIA-N2

non-small cell lung cancer

NSCLC

EGFR mutation

disease-free survival

overall survival