Evaluating Aumolertinib's Effect on Midazolam in Lung Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, fixed-sequence Phase I clinical study investigates how multiple doses of aumolertinib affect the pharmacokinetics of midazolam in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have sensitive EGFR mutations. Participants will receive a single oral dose of midazolam and aumolertinib over a specified treatment period. The study aims to understand the interaction between these two drugs to optimize treatment strategies for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ethics Committee of the First Addiliated Hospital, College of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Qingwei Zhao
• Email: yixuelunli123@163.com
• Phone: 86-571-87236685

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.