OncoMatch/Clinical Trials/NCT06927986
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC(SYNSTAR01)
Is NCT06927986 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06927986 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor therapy (other than EGFR TKI) disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR sensitive mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages