Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Other illness

• History of other primary malignant tumors.
• Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients.
• The investigator assesses whether there are any patients with conditions that may compromise patient safety or interfere with the evaluation of the study, such as poorly controlled hypertension, active bleeding.

Other

• Diagnosis of meningeal metastasis by clinical symptoms or imaging or cerebrospinal fl-uid, or brain parenchymal metastasis combined with meningeal metastasis.
• Female subjects who are pregnant, lactating, or planning to become pregnant during the treatment period.

• At least 18 years old.
• Participants voluntarily signed an informed consent form prior to participation.
• The Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1, no deterioration for at least 1 week before treatment, and the expected survival period is no less than 12 weeks.
• Histologically or cytologically confirmed stage IIIB-IV NSCLC (according to the AJCC eighth edition lung cancer staging criteria), metastatic or recurrent lung cancer that is not amenable to curative intent therapy.
• Positive EGFR mutation confirmed by tissue or cytology(including peripheral blood, pleural effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del).
• No prior systemic therapy was allowed, except in the adjuvant or neoadjuvant setting, and no progression was allowed within 6 months.
• According to RECIST1.1, the patient must have at least one target lung lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as radiation, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter must be ≥15 mm).