Phase 1 Study of Aumolertinib in European Adults With Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the pharmacokinetics PK, safety, and tolerability of aumolertinib in European adults diagnosed with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific activating mutations in the EGFR gene. This Phase 1, open-label, multicenter study focuses on participants whose tumors have mutations such as ex19del, L858R, or T790M. The goal is to better understand how aumolertinib and its metabolites behave in the body and their safety profile in this population. Participants receive aumolertinib orally at a dose of 110 mg once daily under fasting conditions in 21-day treatment cycles. The study has two parts Part A involves detailed PK assessments with visits for blood sampling on specific days within the first two treatment cycles to analyze drug levels. Part B allows participants to continue aumolertinib treatment beyond Cycle 2 until disease progression, intolerable side effects, or other discontinuation reasons determined by the investigator. During the study, participants will undergo safety evaluations and tumor assessments according to clinical needs. Blood samples for PK analysis are collected at multiple time points during the early treatment cycles. After stopping treatment, participants will have an End of Treatment visit within 7 days and a safety follow-up visit approximately 28 days after the last dose. The primary outcomes include measuring drug concentration peaks and exposure over 24 hours, while secondary outcomes focus on adverse events throughout the study, which may last about 18 months on average.

A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer