A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

Prior treatment

• Eligible only for segmentectomy or wedge resection;
• Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;
• Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;
• History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);
• Active or prior history of interstitial lung disease (ILD)/pneumonitis;
• Expected to receive live vaccine therapy within 30 days after randomization;

Other illness

• Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;
• Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;
• T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and/or bulky N2 disease;
• History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);
• Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
• Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);
• History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;

Other

• Pregnant or lactating women;

• Able to understand and voluntarily sign the written informed consent form (ICF);
• Age 18-75 years, regardless of sex;
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;
• Must be eligible for complete surgical resection of the primary tumor;
• Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;
• Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;
• No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);
• At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
• Life expectancy ≥6 months;
• Adequate major organ and bone marrow function;
• Women or men of childbearing potential must use highly effective contraception.
  • 1\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.