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

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).

Trial Details

NCT ID
NCT06926413
Phase
PHASE1
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Aumolertinib；midazolam
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • 1\. Participant should sign an informed consent form before the trial. 2. Male or female age≥18 years, at the time of signing the informed consent.…
  • Participants who have not received any prior anti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or …
  • Participant who received first-generation EGFR-TKI in the locally advanced or metastatic setting and have documented radiological progression prior…
  • 5\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 and no deterioration in the previous two weeks with a minimum li…

For full eligibility, visit ClinicalTrials.gov.

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