WCLC 2025 - Posters & ePosters-EP.18.07 Aumolertinib Combined With Lomustine as First-Line Treatment for EGFR-Mutant NSCLC Patients With Brain Metastasis

EP.18.07 Aumolertinib Combined With Lomustine as First-Line Treatment for EGFR-Mutant NSCLC Patients With Brain Metastasis

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This study investigates the efficacy and safety of combining aumolertinib, a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI), with lomustine, an oral chemotherapy drug, as a first-line treatment for patients with EGFR-mutant non-small cell lung cancer (NSCLC) who have brain metastases. Brain metastasis in EGFR-mutant NSCLC patients is associated with poorer prognosis and treatment challenges.<br /><br />The trial is a phase II, single-arm, prospective study enrolling 131 NSCLC patients harboring EGFR mutations with brain metastasis who have not undergone prior anti-tumor treatment. Patients with an ECOG performance status of 3 or an estimated survival time under 12 weeks are excluded. Participants receive 110 mg of aumolertinib daily and lomustine (100-130 mg/m2) every six weeks until disease progression or treatment intolerance.<br /><br />Primary and secondary endpoints include progression-free survival (PFS) assessed by RECIST1.1 criteria, intracranial PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The combination's all-oral regimen aims to improve patient compliance, reduce hospitalization, and lower infection risks.<br /><br />Previous clinical trials showed third-generation EGFR-TKIs improved median PFS by 5.6-7.2 months compared to first-generation inhibitors in brain metastasis patients, mostly with ECOG 0-1 status. Lomustine crosses the blood-brain barrier effectively and is standard for brain tumors, supporting its use in combination with aumolertinib, which has proven intracranial efficacy.<br /><br />This study represents the first evaluation of combining a third-generation EGFR-TKI with traditional oral chemotherapy for this patient population, potentially offering enhanced intracranial control and better outcomes for EGFR-mutant NSCLC with brain metastases.

Asset Subtitle

Tao Cheng

Meta Tag

Speaker Tao Cheng

Topic Clinical Trials in Progress

Keywords

aumolertinib

lomustine

EGFR-mutant non-small cell lung cancer

brain metastases

third-generation EGFR-TKI

first-line treatment

progression-free survival

intracranial efficacy

oral chemotherapy

phase II clinical trial