Actively Recruiting
A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-04-13
20
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before trial participation
- Male or female aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IIIC/IV) NSCLC
- Must meet one of the following: no prior anti-tumor systemic therapy with tumor harboring EGFR mutations ex19del or L858R (single or combined), or previous first-generation EGFR-TKI treatment with documented progression and tumor harboring EGFR T790M mutation
- ECOG Performance Status score of 0-1 without deterioration in past two weeks and life expectancy of at least 12 weeks
- Use appropriate contraception from screening to 3 months after stopping study treatment; females must not breastfeed
You will not qualify if you...
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and Grade 2 neurotoxicity related to prior platinum therapy
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks before study
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding within two weeks, active infections like HBV, HCV, or HIV
- Past history of interstitial lung disease, drug-induced ILD, radiation pneumonitis requiring steroids, or clinically active ILD
- Refractory nausea, vomiting, chronic GI disorders, inability to swallow oral medication, or significant GI resection affecting drug absorption
- Any condition judged by physician to increase risk or interfere with assessments
- Known hypersensitivity to aumolertinib, midazolam, their analogs, or excipients
- History of ventilation difficulties or severe sleep apnea syndrome
- Acute angle-closure glaucoma or untreated open-angle glaucoma
- Any other condition making participation undesirable or jeopardizing protocol compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ethics Committee of the First Addiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
Q
Qingwei Zhao
CONTACT
K
Ke Niu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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