2022 World Conference on Lung Cancer (ePosters)-EP05.02-009. Aumolertinib Versus Erlotinib/Chemotherapy for Neoadjuvant Treatment of Stage IIIA EGFR-mutant NSCLC (ANSWER)

EP05.02-009. Aumolertinib Versus Erlotinib/Chemotherapy for Neoadjuvant Treatment of Stage IIIA EGFR-mutant NSCLC (ANSWER)

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The ANSWER study is a multicenter, open-label, randomized, controlled trial that aims to assess the efficacy and safety of aumolertinib, a third-generation EGFR-TKI, compared to erlotinib or platinum doublet chemotherapy as neoadjuvant therapy in resectable patients with stage IIIA EGFR-mutant NSCLC. Aumolertinib is a novel drug approved in China for the treatment of EGFR-mutant NSCLC.<br /><br />The study will evaluate the objective response rate (ORR) as the primary endpoint, and secondary endpoints include disease-free survival (DFS), event-free survival (EFS), pathological complete response (pCR), major pathological response (MPR), overall survival (OS), R0 resection rate, and downstaging rate.<br /><br />The patient selection criteria include individuals aged 18-75 years with previously untreated, completely or potentially resectable stage IIIA-N2 nonsquamous NSCLC and confirmed EGFR sensitive mutations. Exclusion criteria include prior surgical resection of lung cancer, prior treatment with any EGFR TKI, chemotherapy or radiotherapy for NSCLC, and concurrent or other active malignancies.<br /><br />The study aims to enroll patients in 24 sites in China, with the first patient expected to be enrolled in September 2021. The estimated study completion is in the fourth quarter of 2025.<br /><br />The goal of the ANSWER study is to provide valuable information on the efficacy and safety of aumolertinib compared to standard treatments in the neoadjuvant setting for stage IIIA EGFR-mutant NSCLC. It may help determine the role of third-generation EGFR-TKIs in this patient population. The study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. More information about the study can be found on the clinicaltrials.gov website.

Asset Subtitle

Wenhua Liang

Meta Tag

Speaker Wenhua Liang

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

Keywords

ANSWER study

aumolertinib

EGFR-TKI

neoadjuvant therapy

stage IIIA NSCLC

efficacy

safety

patient selection criteria

clinical trial

Jiangsu Hansoh Pharmaceutical Group