RecruitingPhase 1NCT07130916

A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer

A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aumolertinib in European Participants With Locally Advanced or Metastatic, EGFR-mutated Non-Small Cell Lung Cancer


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

20 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1, open-label, multicenter, multiple-dose study to evaluate aumolertinib in European participants with a confirmed diagnosis of activating EGFR mutation positive (EGFRm+) locally advanced or metastatic NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing aumolertinib — a targeted therapy for a specific type of lung cancer — in European patients with advanced non-small cell lung cancer (NSCLC) that carries an EGFR mutation. **You may be eligible if...** - You are 18 or older and of European descent living in Europe - You have been diagnosed with advanced or metastatic NSCLC - Your tumor has an EGFR mutation (specifically exon 19 deletion or L858R) - Either you have not yet received treatment for your advanced cancer, OR you have previously received treatment and your cancer progressed on a prior EGFR-targeting drug **You may NOT be eligible if...** - Your lung cancer has small cell elements - You have had unresolved serious side effects from prior treatment - You have had another primary cancer in the past 5 years (with some exceptions) - You have active brain metastases that are not stable - You have a history of serious lung inflammation (ILD/pneumonitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAumolertinib

In Part A, participants will receive aumolertinib 110 mg (2 × 55 mg tablet) once daily, orally administrated under fasted condition (fasting from 2 hours before to 1 hour after dosing) in 21-day treatment cycles. In Part B, participants may continue study intervention (aumolertinib 110 mg once daily) until PD, death, intolerable toxicity, Investigator's decision, lost of follow-up, receiving another anti-cancer therapy, or any other pre-defined discontinuation criteria.


Locations(6)

Republika Srpska University Clinical Centre of the Republic of Srpska, Dvanaest beba bb

Banja Luka, Bosnia and Herzegovina

University Clinical Hospital Mosta, Bijeli Brijeg bb

Mostar, Bosnia and Herzegovina

Clinical Center University of Sarajevo, Bolnicka 25

Sarajevo, Bosnia and Herzegovina

Cantonal Hospital Zenica, Crkvice 67

Zenica, Bosnia and Herzegovina

MHAT "Sveta Sofia" Departmet of Medical Oncology Bulgaria Blvd

Sofia, Grad, Bulgaria

Arensia Exploratory Medicine Moldova - IMSP Institutul Oncologic. Strada Nicolae Testemitanu Nr 30

Chisinau, Moldova

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NCT07130916


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