2024 World Conference on Lung Cancer (WCLC) - Posters-P3.08F.02 MRD Guiding Treatment after Aumolertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model (APPROACH)

P3.08F.02 MRD Guiding Treatment after Aumolertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model (APPROACH)

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The CTONG2101/APPROACH is a phase III clinical study evaluating the efficacy and safety of aumolertinib induction therapy for patients with epidermal growth factor receptor (EGFR) mutations in unresectable stage III non-small cell lung cancer (NSCLC). Traditionally, these patients receive chemoradiotherapy followed by immune-maintenance therapy, but recent studies suggest EGFR-TKI treatment post-chemoradiotherapy extends survival.<br /><br />This open-label, multi-center, randomized trial involves 192 patients who are treatment-naïve, have EGFR exon 19 deletion or 21L858R mutation, and a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). The study explores aumolertinib, administered at 110 mg daily, for 8 weeks as an induction therapy, followed by MDT-assessed local treatment (surgery or chemoradiotherapy). Patients are randomized in a 1:2 ratio into two groups.<br /><br />Group A serves as a control, receiving continuous aumolertinib, while Group B's treatment is guided by minimal residual disease (MRD) status determined through dynamic ctDNA monitoring. If ctDNA is positive, aumolertinib administration continues until it turns negative, allowing for drug holidays. Outcomes include the objective response rate (ORR) after 8 weeks and a 24-month event-free survival (EFS) rate. Secondary endpoints examine various efficacy and safety metrics.<br /><br />Stratification accounts for specifics of EGFR mutations and baseline ctDNA status, ensuring a tailored approach to treatment. The study is active, with the first patient enrolled in June 2023 and aims to complete recruitment by August 2024. Sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd., the trial's results could inform future treatment protocols for stage III NSCLC with EGFR mutations.

Asset Subtitle

Qing Zhou

Meta Tag

Speaker Qing Zhou

Topic Local-Regional NSCLC

Keywords

CTONG2101

APPROACH

aumolertinib

EGFR mutations

NSCLC

chemoradiotherapy

EGFR-TKI

ctDNA monitoring

event-free survival

Jiangsu Hansoh Pharmaceutical