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

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 therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).
• •2. 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).
• •3. Participant who only received one line of first- or second-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.
• •4. Confirmation that the tumor harbors at least one of the EGFR mutations (ex19del, L858R, or T790M) using a clinically validated assay in a licensed laboratory with applicable local accreditation based on tumor tissue and/or circulating tumor deoxyribonucleic acid (ctDNA) in blood.
• •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. Participants must have evaluable disease. At least one measurable (not previously irradiated) and/or non-measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Appendix 6) that can be accurately assessed at baseline and suitable for repeated assessments by computed tomography (CT) or magnetic resonance imaging (MRI) scans. If only one measurable lesion exists, it is acceptable to be used (as a target lesion \[TL\]) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
• •7. Adequate bone marrow reserve or organ function without blood transfusion or growth factor support ≤ 14 days before sample collection at screening as demonstrated by any of the following laboratory values:
• •1. Absolute neutrophil count ≥ 1.5 × 109/L;
• •2. Platelet count ≥ 80 × 109/L;
• •3. Hemoglobin ≥ 90 g/L;
• •4. ALT ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;
• •5. AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;
• •6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases;
• •7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by Cockcroft and Gault equation);
• •8. The confirmation of creatinine clearance is only required when creatinine is ≤ 1.5 × ULN;
• •9. International normalized ratio (INR) ≤ 1.5;
• •10. Activated partial thromboplastin time ≤ 1.5 ULN;
• •8. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• •NOTE: The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
• •Male Participants:
• •• A male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol from screening to three months after the last dose of study intervention.
• •Female Participants:
• •• A female participant is eligible to participate if she has a negative pregnancy test no later than 72 hours prior to start of dosing if of childbearing potential, not breastfeeding from screening to three months after the last dose of the study intervention, and at least one of the following conditions applies:
• •* Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR
• •* A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 from screening to three months after the last dose of study intervention and should not be breastfeeding from screening to three months after the last dose of the study intervention.
• •9. Participant is capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.