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 ofEuropean descent) must be ≥ 18 years of age, at the time of signing the informedconsent.

2. Histological or cytological confirmation diagnosis of newly diagnosed locallyadvanced (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 onCancer [AJCC] Cancer Staging Manual in Lung Cancer), not amenable to curativesurgery 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:

4. Participants who have not received any prior anti-tumor systemic therapy, andthe tumor must harbor at least one of the EGFR mutations (ex19del or L858R).

5. Participants who have received prior neoadjuvant, adjuvant therapies withcurative intent for nonmetastatic disease must have completed treatment for atleast 12 months prior to the development of recurrent or metastatic disease,and the tumor must harbor at least one of the EGFR mutations (ex19del orL858R).

6. Participant who only received one line of first- or second-generation EGFR-TKIin the locally advanced or metastatic setting and have documented radiologicalprogression prior to enrolling in the study, and the tumor must harbor EGFRT790M mutation.

7. 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 withapplicable local accreditation based on tumor tissue and/or circulating tumordeoxyribonucleic acid (ctDNA) in blood.

8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 andno deterioration in the previous two weeks with a minimum life expectancy of 12weeks.

9. Participants must have evaluable disease. At least one measurable (not previouslyirradiated) and/or non-measurable lesions per Response Evaluation Criteria in SolidTumors (RECIST) 1.1 (Appendix 6) that can be accurately assessed at baseline andsuitable for repeated assessments by computed tomography (CT) or magnetic resonanceimaging (MRI) scans. If only one measurable lesion exists, it is acceptable to beused (as a target lesion [TL]) as long as it has not been previously irradiated andas long as it has not been biopsied within 14 days of the baseline tumor assessmentscans.

10. Adequate bone marrow reserve or organ function without blood transfusion or growthfactor support ≤ 14 days before sample collection at screening as demonstrated byany of the following laboratory values:

11. Absolute neutrophil count ≥ 1.5 × 109/L;

12. Platelet count ≥ 80 × 109/L;

13. Hemoglobin ≥ 90 g/L;

14. ALT ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;

15. AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in thepresence of liver metastases;

16. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in thepresence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) orliver metastases;

17. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by Cockcroft and Gault equation);

18. The confirmation of creatinine clearance is only required when creatinine is ≤ 1.5 × ULN;

19. International normalized ratio (INR) ≤ 1.5;

20. Activated partial thromboplastin time ≤ 1.5 ULN;

21. Contraceptive use by men and women must be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies. NOTE: The reliability of sexual abstinence for male and/or female enrollmenteligibility needs to be evaluated in relation to the duration of the clinical studyand the preferred and usual lifestyle of the participant. Periodic abstinence (e.g.,calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal arenot acceptable methods of contraception. Male Participants:

• A male participant must agree to use a highly effective contraception as detailedin Appendix 4 of this protocol from screening to three months after the last dose ofstudy intervention. Female Participants:

• A female participant is eligible to participate if she has a negative pregnancytest 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 studyintervention, 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 fromscreening to three months after the last dose of study intervention and shouldnot be breastfeeding from screening to three months after the last dose of thestudy 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 restrictionslisted in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

1. Any unresolved toxicities from prior therapy greater than Common TerminologyCriteria for Adverse Events (CTCAE) Grade 1 at the time of starting studyintervention with the exception of alopecia and Grade 2 neurotoxicity related toprior platinum-therapy.

2. History of another primary malignancy except for the malignancy treated withcurative intent with no known active disease ≤ 5 years before the first dose ofstudy intervention and of low potential risk for recurrence. Exceptions include, butare not limited to, adequately resected non melanoma skin cancer, and curativelytreated in situ disease.

3. Spinal cord compression or brain metastases unless asymptomatic, stable, and notrequiring steroids for at least four weeks prior to start of study intervention.

4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolledhypertension and active bleeding within two weeks prior to the first dose of studyintervention, active infection (e.g., active HBV infection, HCV infection), or HIVinfection, which in the Investigator's opinion makes it undesirable for theparticipant to participate in the study or which would jeopardise compliance withthe protocol.

5. Any of the following cardiac criteria: mean resting corrected QT (QT; the time fromthe start of the Q wave to the end of the T wave in an ECG) interval corrected forheart rate using Fridericia's correction factor (QTcF) > 470 ms obtained from threeECGs; any clinically important abnormalities in rhythm, conduction or morphology ofresting ECG e.g., complete left bundle branch block, third degree heart block,second degree heart block, PR interval > 250 ms; any factors that increase the riskof corrected QT (QTc) prolongation or risk of arrhythmic events such as heartfailure, hypokalaemia, congenital long QT syndrome, family history of long QTsyndrome or unexplained sudden death under age of 40 or any concomitant medicationknown to prolong the QT interval; Left ventricular ejection fraction (LVEF) ≤ 40%.

6. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiationpneumonitis which required steroid treatment, or any evidence of clinically activeILD.

7. Refractory nausea, vomiting, or chronic GI disorders; Participants unable to swalloworal medication or participants with GI disorders or significant GI resection likelyto interfere with the absorption of study intervention.

8. Participant has any disease or condition that, in the judgment of the physician, mayincrease the risk to the safety or interfering with study assessments.

9. Participant with a known hypersensitivity to study intervention, structural analog,or any of the excipients of the products.

10. Received any of the following treatments:

11. Treatment with a first- or second-generation EGFR-TKI (e.g., erlotinib orgefitinib) within 8 days of the first dose of study intervention or 5half-lives, whichever is the longer.

12. Treatment with prior third-generation EGFR-TKI (e.g., osimertinib).

13. Any cytotoxic chemotherapy, investigational agents or other anticancer drugsfrom a previous treatment regimen or clinical study taken within 14 days of thefirst dose of study intervention or 5 half lives, whichever is longer.

14. Treatment with medications known to be potent strong inhibitors or inducers ofCYP3A4 or narrow therapeutic index drugs for CYP3A4 sensitive substrates (seeAppendix 7) within 7 days of the first dose of study intervention or 5half-lives, whichever is the longer.

15. Major surgery (excluding placement of vascular access) within four weeks of thefirst dose of study intervention.

16. Radiotherapy with a limited field of radiation for palliation within one weekprior to the first dose of study intervention or receiving radiation with morethan 30% of the bone marrow or with a wide field of radiation within four weeksprior to the first dose of study intervention.

17. Participants participated in any interventional clinical study or had been treatedwith any investigational drugs within 28 days or 5 half-lives, whichever is longer,before Screening Visit. Other Exclusion Criteria

18. Participant who, in the judgment of the Investigator, may have poor compliance withthe procedures, limitations, and requirements of the study and are not suitable forenrollment.