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.
Parallel
SYS6010
DrugSYS6010, intravenous injection
Docetaxel
DrugDocetaxel, intravenous injection
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by IRC per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
OS (Overall Survival) in the overall population
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Progression Free Survival (PFS) evaluated by investigator
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by IRC per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
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