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A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC

NCT06926413 ↗

Phase 1 Recruiting 20 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, fixed-sequence Phase I clinical study that evaluates the effect of multiple doses of aumolertinib on the pharmacokinetics of midazolam (CYP 3A4 probe substrate) in sensitive EGFR (Epidermal Growth Factor Receptor) mutation-harboring patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Timeline

Start
2025-02-20
Primary completion
2025-10-31
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Almonertinib Small molecule 110 mg Oral
Subject Midazolam Small molecule 2 mg Oral

Indications

non-small cell lung carcinoma