2022 World Conference on Lung Cancer (ePosters)-EP08.02-137. Prospective Study of Aumolertinib in NSCLC Patients with EGFR Sensitive Mutations Who Are Intolerant to Osimertinib Treatment

EP08.02-137. Prospective Study of Aumolertinib in NSCLC Patients with EGFR Sensitive Mutations Who Are Intolerant to Osimertinib Treatment

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A new prospective study is being conducted to evaluate the safety and efficacy of aumolertinib in advanced non-small cell lung cancer (NSCLC) patients with EGFR-sensitive mutations (EGFRm) who are intolerant to osimertinib treatment. The study aims to assess the success rate of switching to aumolertinib due to safety concerns as the primary endpoint.<br /><br />Phase II and III clinical trials have shown promising results for aumolertinib in treating NSCLC patients with EGFR-sensitive mutations. Compared to other third-generation EGFR-TKIs, aumolertinib has a lower incidence of adverse events such as interstitial lung disease, cardiotoxicity, and hematotoxicity.<br /><br />The study is designed as a prospective, multicenter, single-arm clinical trial. Key inclusion criteria for patients include age between 18-75 years, confirmed EGFR sensitive mutations, advanced NSCLC, safety intolerance after osimertinib treatment, and an estimated survival time of more than 12 weeks. Patients will undergo assessments every 8 weeks until disease progression or the development of specific adverse events.<br /><br />The primary objective of the study is to evaluate the safety of aumolertinib in EGFRm advanced NSCLC patients with safety intolerance after osimertinib treatment. The primary endpoint is the 3-month conversion success rate, defined as the proportion of subjects who did not experience grade 2 hematologic toxicity or grade 3 other adverse events within 3 months of switching to aumolertinib treatment. Secondary endpoints include progression-free survival, objective response rate, overall survival, duration of response, disease control rate, and depth of response.<br /><br />The study is currently enrolling patients, and more information can be found on the clinicaltrials.gov website (NCT04882345). The study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.<br /><br />In conclusion, this prospective study aims to investigate the safety and efficacy of aumolertinib in EGFRm advanced NSCLC patients intolerant to osimertinib. The results of this study may provide valuable insights into the use of aumolertinib as a treatment option for this patient population.

Asset Subtitle

Shun Lu

Meta Tag

Speaker Shun Lu

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

prospective study

aumolertinib

advanced non-small cell lung cancer

NSCLC

EGFR-sensitive mutations

osimertinib treatment

safety concerns

third-generation EGFR-TKIs

adverse events

clinical trial