Evaluating Aumolertinib's Effect on Midazolam in Lung Cancer Patients

An Open-label, Fixed-sequence Phase I Clinical Study Evaluating the Effect of Multiple Oral Doses of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer (NSCLC)

This study is testing how a new lung cancer drug, aumolertinib, affects the way the body processes another medication, midazolam, in patients with advanced non-small cell lung cancer who have specific genetic changes.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: Aumolertinib, radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06926413 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic NSCLC harboring specific EGFR mutations.

Not a fit: Patients without EGFR mutations or those with early-stage lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of drug interactions in NSCLC treatment, potentially leading to improved therapeutic outcomes.

How similar studies have performed: While this specific approach is novel, similar studies evaluating drug interactions in cancer treatments have shown promising results.

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.

Where this trial is running

Hangzhou, Zhejiang

• Ethics Committee of the First Addiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Qingwei Zhao

Conditions: Non Small Cell Lung Cancer