A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer
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.
| Condition(s) | Non-Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Male or female European participants (inhabitant of a European country and of European descent) must be ≥ 18 years of age, at the time of signing the informed consent. 2. Histological or cytological confirmation diagnosis of newly diagnosed locally advanced (clinical stage IIIB or IIIC) or metastatic (clinical stage IVA or IVB) NSCLC or recurrent NSCLC (per The Eighth Edition of The American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual in Lung Cancer), not amenable to curative surgery or definitive radiotherapy with or without chemotherapy. NOTE: if small cell elements are present, the participant is ineligible. 3. Prior anti-tumor systemic therapy. Participant must fulfill one of below: 1. Participants who have not received any prior anti-tumor systemic |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Locations | Banja Luka, Bosnia and Herzegovina; Mostar, Bosnia and Herzegovina; Sarajevo, Bosnia and Herzegovina; Zenica, Bosnia and Herzegovina; Sofia, Grad, Bulgaria; Chisinau, Moldova |
| Start date | 2024-12-05 |
| NCT ID | NCT07130916 |
| Official listing | https://clinicaltrials.gov/study/NCT07130916 |