A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC

Exclusion Criteria20

• Histologically or cytologically confirmed combined small cell lung cancer (SCLC), neuroendocrine carcinoma, sarcomatoid carcinoma, or carcinosarcoma components.
• Subjects with a history of leptomeningeal metastasis, brainstem metastasis, or spinal cord metastasis.
• Subjects with uncontrolled tumor-related pain, as determined by the investigator.
• Clinically uncontrolled third-space fluid accumulation, as determined by the investigator.
• Insufficient time interval between prior antitumor therapy and the first dose administration.
• Major organ surgery or significant trauma within 4 weeks prior to the first dose of the study drug.
• History of other malignancies within ≤5 years prior to the first dose.
• Subjects with a history of interstitial lung disease, or imaging at screening suggestive of suspected interstitial lung disease; or other moderate to severe pulmonary diseases severely affecting lung function.
• Severe cardiovascular or cerebrovascular diseases.
• Any severe or uncontrolled ocular lesions that, in the physician's judgment, may increase the patient's safety risk.
• Refractory nausea, vomiting, chronic gastrointestinal diseases, etc.
• Severe infections within 4 weeks prior to the first dose.
• Subjects with arterial/venous thromboembolic events within 6 months prior to the first dose of the study drug.
• Active tuberculosis infection.
• History of immunodeficiency, including positive HIV test.
• Active hepatitis B or hepatitis C.
• Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.
• History of severe allergic reactions to aumolertinib or other monoclonal antibodies, or hypersensitivity to any component of SHR-A2009.
• Known history of alcohol or drug dependence or drug abuse.
• Psychiatric disorders or poor compliance.