NCT06926413 A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC
| NCT ID | NCT06926413 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-02-20 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion 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. 3. Histologically or cytological confirmation diagnosis of locally advanced or metastatic (IIIB/IIIC/IV) NSCLC; 4. Participant must fulfill one of below: 1. 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 L858R, single mutation or combined with other EGFR mutations are both acceptable). 2. Participant who received first-generation EGFR-TKI in the locally advanced or metastatic setting and have documented radiological progression prior to enrolling in the study, and the tumor must harbor EGFR T790M mutation. 5\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 and no deterioration in the previous two weeks with a minimum life expectancy of 12 weeks. 6\. Male or female should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and female should not breastfeed. Exclusion Criteria: * 1\. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention with the exception of alopecia and Grade 2 neurotoxicity related to prior platinum-therapy. 2\. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks prior to start of study intervention. 3\. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding within two weeks prior to the first dose of study intervention, active infection (e.g., active HBV infection, HCV infection), or HIV infection, which in the Investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardise compliance with the protocol. 4\. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 5\. Refractory nausea, vomiting, or chronic GI disorders; Participants unable to swallow oral medication or participants with GI disorders or significant GI resection likely to interfere with the absorption of study intervention. 6\. Participant has any disease or condition that, in the judgment of the physician, may increase the risk to the safety or interfering with study assessments. 7\. Participant with a known hypersensitivity to study intervention (Aumolertinib and Midazolam), structural analog, or any of the excipients of the products. 8\. Past medical history of ventilation difficulties or severe sleep apnea syndrome. 9\. Patient with acute angle-closure glaucoma or untreated open-angle glaucoma. 10. Patient which in the Investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardise compliance with the protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06926413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06926413 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06926413 currently recruiting?
Yes, NCT06926413 is actively recruiting participants. Contact the research team at yixuelunli123@163.com for enrollment information.
Where is the NCT06926413 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06926413 clinical trial?
NCT06926413 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. The trial plans to enroll 20 participants.
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