An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer

Starting soon · Phase 1

Conditions studied: NSCLC

In brief

This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with EGFR-TKIs.

Key facts

Study ID

NCT07685041

Run by

Jiangsu Hansoh Pharmaceutical Co., Ltd.

People needed

24

Starts

2026-06-27

Expected to finish

2027-07-20

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed locally advanced or metastatic NSCLC
• Disease progression or intolerance to prior third-generation EGFR TKI therapy in patients with mNSCLC
• Confirmed EGFR mutation positivity in participants before enrollment.
• At least one target lesion according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 with no deterioration in the 2 weeks prior to the first dose
• Minimum life expectancy greater than 12 weeks
• Female participants of childbearing potential must agree to use appropriate contraception (refer to section 12.5) from the time of signing informed consent until 6 months after the last dose, and should not breastfeed; male participants must agree to use barrier contraception (i.e., condoms) from the time of signing informed consent until 6 months after the last dose
• Willing to participate in this clinical trial, understand the study procedures, and be able to provide written informed consent.

You may not qualify if…

• Has received or is currently receiving the following treatments:
• Prior or current treatment with a fourth-generation EGFR tyrosine kinase inhibitor.
• Use of strong/moderate inhibitors or strong/moderate inducers of CYP3A4, CYP3A5, CYP2C8, and/or CYP2D6, or narrow therapeutic index drugs that are sensitive substrates of CYP3A4, CYP3A5, P-gp, and BCRP within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product; or need to continue these medications during the study period.
• Use of drugs that affect gastric acid secretion or intragastric pH within 7 days prior to the first dose of investigational product.
• Currently receiving treatment with drugs known to prolong the QT interval or that may cause torsade de pointes; or need to continue these medications during the study period
• Presence of toxicities from prior anti-tumor therapy that have not resolved to < Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
• History of other primary malignancies.
• Inadequate bone marrow reserve or hepatic/renal organ function.
• Meets any of the following cardiac criteria:
• Mean Fridericia-corrected QT interval (QTcF) > 470 msec on resting electrocardiogram (ECG);
• Resting ECG shows any clinically significant rhythm, conduction, or ECG morphological abnormality deemed important by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval > 250 msec, etc.);
• Presence of any factors that increase the risk of QT prolongation or arrhythmic events, such as heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication that prolongs the QT interval;
• Left ventricular ejection fraction (LVEF) < 50%.
• Severe, uncontrolled, or active cardiovascular disease.
• Severe or poorly controlled diabetes mellitus.
• Severe or poorly controlled hypertension.
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
• Severe arterial thrombotic event within 3 months prior to the first dose.
• Severe infection within 4 weeks prior to the first dose.
• Continuous corticosteroid therapy for more than 30 days within 30 days prior to the first dose, or need for long-term corticosteroid therapy, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
• Known active infectious disease.
• Clinically severe gastrointestinal abnormalities that may affect drug intake, transport, or absorption.
• Hepatic encephalopathy, hepatorenal syndrome, or ≥C (incomplete in original).
• Other moderate to severe pulmonary diseases that seriously impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
• Previous history of severe neurological or psychiatric disorders.

Full record on ClinicalTrials.gov

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