2024 Asia Conference on Lung Cancer (ACLC) - Poster & ePosters-PP02.33

PP02.33 - Si-Yang Liu

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The FATES study (CTONG2105) is a phase II clinical trial examining the role of molecular residual disease (MRD)-guided adjuvant therapy in patients with resectable, EGFR-mutated, stage IB-IIIB non-small cell lung cancer (NSCLC). The study aims to assess the efficacy and tolerability of personalized treatment using EGFR-tyrosine kinase inhibitors (EGFR-TKIs), contingent on MRD status, which helps in deciding therapy upon formation or eradication of detectable MRD.<br /><br />The trial recruits NSCLC patients who have undergone complete resection and possess EGFR-sensitive mutations. Participants are categorized based on their MRD status post-surgery. Those with positive MRD are initially treated with icotinib; treatment is discontinued upon MRD negativity. Conversely, patients with negative MRD initially undergo observation, with osimertinib therapy initiated if MRD turns positive.<br /><br />The study's main objectives are to compare the 3-year disease-free survival (DFS) rate and the median DFS between the MRD-positive and MRD-negative groups. MRD and imaging assessments occur every 12 weeks until trial withdrawal.<br /><br />Sponsored by Changzhou Tongshu Biotechnology Co., Ltd., and led by Prof. Yi-Long Wu, the study began enrolling participants in November 2022, with the aim of enrolling 180 patients by September 2024. This study is particularly important as it is the first prospective trial to investigate whether a drug holiday is feasible in the adjuvant setting based on dynamic MRD status, which could reduce treatment toxicity, as well as psychological and financial burdens on patients. The trial is registered under NCT05536505.

Keywords

FATES study

CTONG2105

molecular residual disease

MRD-guided therapy

EGFR-mutated NSCLC

EGFR-TKIs

icotinib

osimertinib

disease-free survival

Changzhou Tongshu Biotechnology