OncoMatch/Clinical Trials/NCT06927986
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
Is NCT06927986 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including SYS6010 and Pemetrexed for egfr-mutated locally advanced or metastatic nsclc.
Treatment: SYS6010 · Pemetrexed · Cisplatin · Carboplatin — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR sensitive mutation
Allowed: EGFR t790m
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor — locally advanced or metastatic
Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy
Cannot have received: systemic anti-tumor therapy (other than EGFR TKI)
Exception: adjuvant/neoadjuvant chemotherapy with progression >12 months after end of treatment is allowed
Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant/neoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Hemoglobin ≥100g/L
Kidney function
Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert syndrome/liver mets); ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN for liver mets)
Cardiac function
No severe cardiac rhythm/conduction abnormalities, QTcF >470 ms, NYHA class II or higher cardiac failure, LVEF<50%, recent MI/angina/aortic dissection/angioplasty/CABG, stroke, pulmonary embolism
Major organ function must meet the following criteria within 7 days prior to randomization...see full details in eligibility
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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