This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.
Driver gene-negative population must have failed only immune therapy and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
Other driver gene-positive populations must have received and failed only targeted therapy for the driver gene and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
ANC ≥1.5×10⁹/L
Platelets (PLT) ≥100×10⁹/L
Histologically or cytologically confirmed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma
Patients with: Leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastases.
Other malignancies within 3 years before randomization, except: Cured basal/squamous cell skin cancer, superficial bladder cancer, prostate/cervical carcinoma in situ.
Known allergies: To any component of SYS6010 or humanized monoclonal antibodies. Contraindications/hypersensitivity to docetaxel.