A Phase III Study to Assess the Efficacy and Safety of Almonertinib Versus Platinum-based Chemotherapy as First-line Therapy in Patients With Locally Advanced or Metastatic NSCLC Harbouring Uncommon EGFR Mutation

Inclusion Criteria:

1. Subjects are willing to participate in this clinical study, understand the studyprocedures and are able to sign the informed consent in person.
2. Age at least 18 years.
3. Histologically or cytologically confirmed diagnosis of primary non-small lung cancer (NSCLC), histologically confirmed non-squamous pathology.
4. Locally advanced or metastatic NSCLC.
5. Patients must be treatment-naïve for locally advanced or metastatic NSCLC.
6. The tumor harbors uncommon EGFR mutations (one of the following EGFR mutation: L861Q,G719X or S768I), assessed by Xiamen AmoyDx EGFR (ADx-ARMS, Super-ARMS method) kit incentral laboratory.
7. Measurable disease by RECIST 1.1.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Female patients should be using adequate contraceptive measures and should not bebreastfeeding during the study and six months after the last dosing of study. Malepatients should be willing to use barrier contraception (condoms) during the study andsix months after the last dosing of study.
10. A pregnancy test should be done before randomization unless having an evidence ofnon-child-bearing potential.

Exclusion Criteria:

1. Treatment with any of the following:
2. Prior treatment with EGFR-TKI therapy.
3. Radiotherapy treatment to more than 30% of the bone marrow or with a wide fieldof radiation within 4 weeks prior to randomization.
4. The presence of pleural effusion/peritoneal effusion/pericardial effusionrequiring clinical intervention.
5. Major surgery within 4 weeks prior to randomization.
6. Spinal cord compression or unstable brain metastasis; Meningeal or brainstemmetastases.
7. Patients had received medications or herbal supplements known to be stronginducers and inhibitors of cytochrome CYP3A4 within 7 days prior to randomizationor required to continue these agents during the study period.
8. Patients are receiving medications known to prolong QT interval or may cause tiptorsion ventricular tachycardia, or are still in the washout period (relativelyrandom phase), or need to be continued during the study period.
9. Patients were subjects in another clinical trial within 4 weeks prior torandomization or patients were within 5 half-lives of any other investigationalagent.
10. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2 from the prior anticancer therapy.
11. Inadequate bone marrow reserve or organ function.
12. Any of the following cardiac criteria:
13. Mean resting corrected QT interval (QTc) > 470 ms obtained from 3electrocardiograms (ECGs), using the screening clinic's ECG machine andFridericia's formula for QT interval correction (QTcF).
14. Any clinically important abnormalities in rhythm, conduction, or morphology ofthe resting ECG (e.g., PR interval > 250 ms).
15. Any factors that increase the risk of QTc prolongation or risk of arrhythmicevents, such as heart failure or any concomitant medication known to prolong theQT interval.
16. Left ventricular ejection fraction (LVEF) <50%.
17. History of other malignancies, excluding fully treated non-melanoma skin cancer,Malignant freckled nevus, in-situ cancer, other solid tumors that hadn't beenrecurrent for > 5 years following the end of treatment, or local prostate cancer afterradical resection.
18. Any evidence of severe or uncontrolled systemic diseases (including uncontrolledhypertension and active bleeding diatheses) or active infection (including hepatitisB, hepatitis C, and human immunodeficiency virus (HIV), etc.).
19. Acquired or congenital immune deficiency diseases, or history of organtransplantation.
20. Serious gastrointestinal function abnormalities that may interfere with drugingestion, transport, or absorption.
21. Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion,present a specific risk to the patient's safety.
22. Pregnant or lactating, or intending to become pregnant during the study
23. Judgment by the investigator that the patient should not participate in the study ifthe patient is unlikely to comply with study procedures, restrictions, andrequirements.
24. Any disease or condition that, in the opinion of the investigator, would compromisethe safety of the patient or interfere with study assessments.