SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ (NCT07442565) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ
506 participantsStarted 2026-03-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Hemoglobin (HGB) ≥100 g/L
✓. Serum creatinine (Cr) ≤1.5×ULN AND creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula)
✓. Total bilirubin (TBIL): ≤1.5×ULN for patients without liver metastases; ≤3×ULN for patients with Gilbert's syndrome or liver metastases
✓. ALT/AST: ≤2.5×ULN for patients without liver metastases; ≤5×ULN for patients with liver metastases
Exclusion criteria
✕. 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.
What they're measuring
1
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.