Actively Recruiting
A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-08-19
20
Participants Needed
6
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female European participants aged 18 years or older at consent
- Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IVA or IVB) NSCLC or recurrent NSCLC not suitable for curative surgery or definitive radiotherapy
- Prior anti-tumor systemic therapy as specified: either no prior systemic therapy with tumor harboring ex19del or L858R mutations; or completed curative neoadjuvant/adjuvant therapy at least 12 months before recurrence with ex19del or L858R mutations; or prior treatment with first- or second-generation EGFR-TKI with documented progression and tumor harboring T790M mutation
- Confirmation of EGFR mutation (ex19del, L858R, or T790M) by a validated assay from tumor tissue or circulating tumor DNA
- ECOG Performance Status score of 0 or 1 with no recent deterioration and minimum life expectancy of 12 weeks
- Presence of evaluable disease with at least one measurable or non-measurable lesion suitable for repeated imaging assessments
- Adequate bone marrow and organ function as defined by specific laboratory values
- Use of effective contraception according to local regulations from screening to three months post last dose
- Ability to provide signed informed consent and comply with study requirements
You will not qualify if you...
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and certain neurotoxicities
- History of other primary malignancies except those treated curatively with no active disease for at least 5 years
- Spinal cord compression or brain metastases unless asymptomatic, stable, and steroid-free for at least 4 weeks
- Severe or uncontrolled systemic diseases including active infections or conditions affecting study participation
- Cardiac abnormalities including prolonged QTc interval, conduction disorders, or low ejection fraction
- History or evidence of interstitial lung disease or related lung conditions requiring steroid treatment
- Severe gastrointestinal disorders affecting medication absorption or ability to swallow oral drugs
- Known hypersensitivity to aumolertinib or its components
- Recent use of specified anticancer drugs, EGFR-TKIs, investigational agents, or CYP3A4 inhibitors/inducers within defined washout periods
- Major surgery or radiotherapy within specified recent timeframes
- Participation in other interventional trials or investigational drug use within 28 days prior to screening
- Any condition judged by the investigator to increase safety risk or interfere with study assessments
- Poor compliance potential as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Republika Srpska University Clinical Centre of the Republic of Srpska, Dvanaest beba bb
Banja Luka, Bosnia and Herzegovina, 78000
Actively Recruiting
2
University Clinical Hospital Mosta, Bijeli Brijeg bb
Mostar, Bosnia and Herzegovina, 78000
Actively Recruiting
3
Clinical Center University of Sarajevo, Bolnicka 25
Sarajevo, Bosnia and Herzegovina, 71000
Actively Recruiting
4
Cantonal Hospital Zenica, Crkvice 67
Zenica, Bosnia and Herzegovina, 72000
Actively Recruiting
5
MHAT "Sveta Sofia" Departmet of Medical Oncology Bulgaria Blvd
Sofia, Grad, Bulgaria, 104 1404
Actively Recruiting
6
Arensia Exploratory Medicine Moldova - IMSP Institutul Oncologic. Strada Nicolae Testemitanu Nr 30
Chisinau, Moldova, MD-2025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here