Aumolertinib Combined With Phased Chemotherapy for EGFR L858R Lung Adenocarcinoma

Background: While third-generation EGFR tyrosine kinase inhibitors (TKI) like aumolertinib have significantly improved outcomes for patients with advanced lung adenocarcinoma, those harboring the L858R mutation still experience inferior prognosis compared to those with exon 19 deletions. Recent evidence suggests that combining TKIs with chemotherapy improves progression-free survival (PFS), but universal application of this combination exposes all patients to cytotoxic toxicity, even those who might thrive on TKI monotherapy alone. Circulating cell-free DNA (cfDNA) and minimal residual disease monitoring offer a dynamic window to identify which patients truly require treatment intensification. Objectives: The primary objective is to evaluate the predictive value of early molecular response by determining the association between the change in EGFR mutant allele fraction in cfDNA after a 6-week aumolertinib lead-in induction phase (T1) and a 4-cycle combination chemotherapy (T2) with clinical PFS. Secondary objectives include assessing overall response rates (ORR), disease control rate (DCR), safety, and the dynamics of EGFR mutant allele fraction and circulating immune cell profiles. Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial enrolling 50 evaluable patients. The study utilizes a three-phase treatment framework: * Induction Phase: Aumolertinib monotherapy (110 mg/day) once daily for 6 weeks. * Consolidation Phase: Combination of aum…

This description comes directly from the study's public registry record.

Yi-Ting Lin  ·  886-2-27372181  ·  216165@h.tmu.edu.tw

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