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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.

Phase 3RecruitingCSPC Megalith Biopharmaceutical Co.,Ltd.NCT06927986Data as of Jun 2026Location: China

Treatment: SYS6010 · Pemetrexed · Cisplatin · CarboplatinTo 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)

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Extracted eligibility criteria

Treatments studied

Chemotherapy

PemetrexedCisplatinCarboplatin

Other

SYS6010

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

Ages ≤ 75

Prior therapy

Min 1 prior line

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.

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