Actively Recruiting
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2025-11-17
380
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
CONDITIONS
Official Title
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Pathologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations
- Have failed prior EGFR TKI therapy, including third-generation TKIs if T790M mutation was positive
- At least one measurable tumor lesion confirmed by CT or MRI scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate major organ function within 7 days prior to randomization, including specific blood counts, kidney and liver function, and coagulation parameters
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization and agree to use effective contraception during the study and for 7 months after
- Voluntary participation with ability to understand and sign informed consent
You will not qualify if you...
- Combined small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or carcinosarcoma
- Active central nervous system metastases or unstable brain metastases requiring corticosteroids >10 mg prednisone daily
- History of other malignant tumors within 3 years except certain cured or in situ cancers
- Allergy to SYS6010, monoclonal antibodies, carboplatin, cisplatin, or pemetrexed
- Unresolved adverse events from prior anti-tumor treatments above Grade 1 (with some exceptions)
- Prior systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI (with some timing exceptions)
- Recent major surgery, targeted drugs, radiotherapy, antibiotics, investigational products, or strong enzyme inhibitors within specified washout periods
- Severe cardiovascular or cerebrovascular disease within 6 months, including certain heart rhythm issues, myocardial infarction, heart failure, stroke, or pulmonary embolism
- Tumor invasion of major vessels with bleeding risk
- History or presence of interstitial lung disease or severe lung function impairment
- Severe infections or active infections requiring systemic antibiotics recently
- Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity or current skin diseases requiring systemic medication
- History of ulcerative colitis or Crohn's disease
- Pleural or pericardial effusion requiring clinical intervention within 2 weeks
- Active hepatitis B or C infection above specified viral load thresholds
- History of immunodeficiency, stem cell or organ transplant
- Other conditions deemed unsuitable by the investigator, including mental disorders, severe eye disorders, or uncontrolled hypertension or diabetes mellitus
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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