2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.08F.03 Efficacy and Safety of Aumolertinib with Radiotherapy in the Treatment of Unresectable Locally Advanced EGFR-Mutant NSCLC: A Phase II Study

EP.08F.03 Efficacy and Safety of Aumolertinib with Radiotherapy in the Treatment of Unresectable Locally Advanced EGFR-Mutant NSCLC: A Phase II Study

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The document presents an overview of a Phase II study, POLESTAR 2, investigating the efficacy and safety of combining aumolertinib with radiotherapy for patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) who harbor EGFR mutations and are intolerant to chemotherapy. Typically, approximately 30% of NSCLC patients are diagnosed at stage III, with standard treatment being platinum-based concurrent chemoradiotherapy (cCRT). However, within 1-2 years, up to 80% of patients experience recurrence, and existing immunotherapy options like those highlighted in the PACIFIC study have shown limited efficacy for patients with EGFR mutations.<br /><br />This study aims to explore a chemotherapy-free regimen of aumolertinib, a third-generation EGFR-TKI that has demonstrated high selectivity and low toxicity for EGFR-sensitive mutations. The trial includes 27 patients, aged 18-80, with unresectable locally advanced NSCLC (harboring EGFR mutations with exon 19 deletions or L858R), who refuse chemotherapy. Participants receive aumolertinib at a dosage of 110 mg orally, once daily, alongside concurrent radiotherapy (56-66 Gy, split into 1.8-2.0 Gy fractions), continuing until disease progression or intolerance.<br /><br />The study's primary endpoint is progression-free survival (PFS) as assessed by RECIST 1.1 criteria. Secondary endpoints include overall survival (OS), time to central nervous system progression, time to distant metastasis, objective response rate, disease control rate, and duration of response. Safety outcomes involve monitoring adverse events throughout the trial. The research aims to provide insights into aumolertinib's potential as a viable therapy for EGFR-mutant NSCLC patients who cannot undergo traditional chemotherapy.

Asset Subtitle

XIANGJIAO MENG

Meta Tag

Speaker XIANGJIAO MENG

Topic Local-Regional Non-small Cell Lung Cancer

Keywords

POLESTAR 2

aumolertinib

radiotherapy

non-small cell lung cancer

EGFR mutations

chemotherapy intolerance

progression-free survival

third-generation EGFR-TKI

unresectable NSCLC

oncology study