SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ

Exclusion Criteria

• •1. Histologically or cytologically confirmed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma
• •2. Patients with: Leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastases.
• •Exception: Supratentorial and/or cerebellar metastases (excluding midbrain, pons, or medulla) are allowed if: Received local therapy (e.g., radiation/surgery) Stable for ≥2 weeks before randomization (no new lesions/enlargement on imaging, stable/improved neurological symptoms). No corticosteroids or ≤10 mg prednisone (or equivalent) daily.
• •3. Other malignancies within 3 years before randomization, except: Cured basal/squamous cell skin cancer, superficial bladder cancer, prostate/cervical carcinoma in situ.
• •4. Known allergies: To any component of SYS6010 or humanized monoclonal antibodies. Contraindications/hypersensitivity to docetaxel.
• •5. Residual toxicities from prior antitumor therapy \> Grade 1 (per NCI-CTCAE v6.0), except: Grade 2 alopecia or other toxicities deemed non-risky by investigators.
• •6. Prior treatment with topoisomerase I inhibitors (including ADCs).
• •7. Inadequate washout periods:
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• •1. Major surgery (excluding biopsies) within 4 weeks before first dose.
• •2. Last antitumor therapy before first dose:
• •Chemotherapy/radical radiotherapy/targeted/immunotherapy: ≥4 weeks. Small-molecule targeted drugs/TCM with antitumor claims/palliative radiotherapy/local therapy: ≥2 weeks.
• •3. Within 2 weeks before first dose: IV antibiotics/antifungals/antivirals for the purpose of anti-infective therapy; strong CYP3A4 inducers/inhibitors; OATP1B1/1B3 inhibitors.
• •4. Investigational drugs/live vaccines within 4 weeks before first dose. 8. Severe cardiovascular diseases within 6 months before randomization, including: Clinically significant arrhythmias (e.g., ventricular arrhythmia, AV block ≥ Grade III); QTcF \>470 ms (Fridericia's formula) Myocardial infarction, unstable angina, aortic dissection, angioplasty, CABG. Heart failure ≥ NYHA Class II or LVEF \<50%. Stroke or Grade ≥3 cardiovascular events. Pulmonary embolism. 9. History of ILD/non-infectious pneumonitis requiring steroids; current ILD; or suspected ILD on imaging/pulmonary function tests (severe ventilation/diffusion impairment).
• •10\. Severe infections within 4 weeks before randomization (e.g., bacteremia, severe pneumonia, active TB); active infections requiring IV antibiotics within 2 weeks.
• •11\. History of ulcerative colitis or Crohn's disease. 12. Pleural/pericardial effusion requiring intervention within 2 weeks. 13. Active HBV/HCV infection: HBV: HBsAg+ and/or HBcAb+ with HBV DNA ≥10⁴ copies/mL (or ≥2000 IU/mL).
• •HCV: HCV Ab+ with HCV RNA above detection limit. Note: Antiviral therapy (e.g., entecavir/tenofovir) is recommended for HBsAg+ patients before randomization.
• •14\. Immunodeficiency (HIV+, congenital/acquired immune disorders) or allogeneic transplant history.
• •15\. Other conditions deemed ineligible by investigators (e.g., uncontrolled psychiatric disorders, hypertension/diabetes).