NCT07130916

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

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aumolertinib in European Participants With Locally Advanced or Metastatic, EGFR-mutated Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter, multiple-dose study to evaluate aumolertinib in European participants with a confirmed diagnosis of activating EGFR mutation positive (EGFRm+) locally advanced or metastatic NSCLC.

Detailed description

The purpose of this study is to evaluate the PK profile, safety, and tolerability of aumolertinib in European participants with locally advanced or metastatic NSCLC harboring at least one of the EGFR mutations (ex19del, L858R, or T790M). All enrolled participants will receive the study intervention at selected oral dose(s) once daily throughout 21 day cycles. Study details include: Part A: During study Part A, participants will be required to present at the study site for PK assessments on Days 1, 2, 8, and 15 of treatment Cycle 1, and on Days 1 and 2 of treatment Cycle 2. Part A will undergo safety assessments and will characterize the PK of aumolertinib and related metabolites following single and multiple doses. PK samples are to be collected pre-dose (within 1 hour prior to dosing) of treatment with aumolertinib on Days 8 and 15 of treatment Cycle 1, and on Day 1 of treatment Cycles 1 and 2 at the following timepoints: pre-dose (within 1 hour prior to dosing) and 1-, 2-, 3-, 4-, 5-, 6-, 8-, 10 , 12-, and 24-hour (Day 2) post-dose. Part B: During Part B of the study (i.e., Day 3 of treatment Cycle 2, and beyond), participants may continue study intervention until PD, death, intolerable toxicity, Investigator's decision, lost of follow-up, receiving another anti-cancer therapy, or any other pre-defined discontinuation criteria. Participants will undergo safety assessments and tumor evaluation according to clinical indication. The End of Treatment Visit will be conducted within 7 days after determining the participants' discontinuation of the study intervention. The Safety Follow-up (SFU) Visit will be conducted 28 (± 7) days after the last dose of study intervention.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Aumolertinib	In Part A, participants will receive aumolertinib 110 mg (2 × 55 mg tablet) once daily, orally administrated under fasted condition (fasting from 2 hours before to 1 hour after dosing) in 21-day treatment cycles. In Part B, participants may continue study intervention (aumolertinib 110 mg once daily) until PD, death, intolerable toxicity, Investigator's decision, lost of follow-up, receiving another anti-cancer therapy, or any other pre-defined discontinuation criteria.

Timeline

• Start date: 2024-12-05
• Primary completion: 2025-08-09
• Completion: 2027-12-31
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

6 sites across 3 countries: Bosnia and Herzegovina, Bulgaria, Moldova