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.
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.
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.
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).
Participants who have received prior neoadjuvant, adjuvant therapies with curative intent for nonmetastatic disease must have completed treatment for at least 12 months prior to the development of recurrent or metastatic disease, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).
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.
History of another primary malignancy except for the malignancy treated with curative intent with no known active disease ≤ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include, but are not limited to, adequately resected non melanoma skin cancer, and curatively treated in situ disease.
Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks prior to start of study intervention.
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.
Single group
Aumolertinib
DrugIn 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.
Tmax of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Time to reach Cmax
Cmax of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Maximum plasma concentration
AUC0-24h of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Area under the plasma concentration-time curve form 0-24h
Cmin of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Minmum plasma concentration
Adverse events (AEs) of aumolertinib administered in European participants with locally advanced or metastatic, EGFR-mutated NSCLC.
Incidence and severity of advese event
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