To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.
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;
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;
Eligible only for segmentectomy or wedge resection;
Parallel
SYS6010
DrugSYS6010 by intravenous (IV) infusion
Osimertinib
DrugOsimertinib, oral
Pemetrexed
Drug500 mg/m\^2 by IV infusion, Q3W
Cisplatin
Drug75 mg/m\^2 by IV infusion, Q3W
Carboplatin
DrugAUC 5 mg/mL•min by IV infusion, Q3W
Major Pathological Response (MPR) Rate
Defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor bed, as assessed by blinded independent pathological review (BIPR).
Pathological Complete Response (pCR) Rate
The proportion of participants with no residual viable tumor cells in both the resected primary tumor bed and lymph nodes, as assessed by BIPR.
Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery
Disease-Free Survival (DFS)
Investigator-assessed DFS per RECIST v1.1
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