An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Ph… (NCT07685041) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
24 participantsStarted 2026-06-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of PK parameters of Midazolam: Cmax
Timeframe: 24 hours after administration of Midazolam
2
Evaluation of PK parameters of Midazolam: AUC0-t
Timeframe: 24 hours after administration of Midazolam
3
Evaluation of PK parameters of Midazolam: AUC0-∞
Timeframe: 24 hours after administration of Midazolam
. Willing to participate in this clinical trial, understand the study procedures, and be able to provide written informed consent.
Exclusion criteria
. 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.