Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）

NCT06927986 | Recruiting Phase 3 DMC

• 1 other identifier: SYS6010-011
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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

EGFR-mutated Locally Advanced or Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by independent review committee (IRC)

  Defined as the time from randomisation until the date of objective disease progression or death was assessed by IRC according to RECIST 1.1

  Up to approximately 1.5 years

Secondary Outcomes (12)

• Investigator-assessed PFS

  Up to approximately 1.5 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Objective response rate (ORR)

  Up to approximately 1.5 years

• Overall Survival (OS)

  Up to approximately 2 years

• Incidence of adverse events (AEs)

  Up to approximately 2 years

Study Arms (2)

SYS6010

EXPERIMENTAL

Drug: SYS6010

Platinum-containing chemotherapy

ACTIVE COMPARATOR

Pemetrexed injection 500 mg/m\^2 + cisplatin 75 mg/m\^2 or carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Interventions

SYS6010 DRUG

SYS6010,Q3W

SYS6010

Pemetrexed DRUG

Pemetrexed injection 500 mg/m\^2 administered via intravenous infusion，Q3W

Platinum-containing chemotherapy

Cisplatin DRUG

Cisplatin 75 mg/m\^2 administered via intravenous infusion，Q3W

Platinum-containing chemotherapy

Carboplatin DRUG

Carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Platinum-containing chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 (inclusive) years old, male or females;
• Patients with pathologically confirmed locally advanced or metastatic NSCLC, including those with stage IIIB or IIIC based on 8th edition of the AJCC staging system who are not suitable for surgical resection or radical chemoradiotherapy, or those with stage IV NSCLC. Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy，whereas patients progressed on first- or second-generation EGFR-TKIs must have also progressed on third-generation EGFR-TKIs if T790M mutation was detected as postive status.
• Presence of at least one EGFR-sensitive mutation;
• At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria;
• ECOG performance status of 0-1;
• Life expectancy ≥ 3 months;
• Major organ function must meet the following criteria within 7 days prior to randomizationn (No component transfusion, G-CSF, TPO, IL-11, or EPO within 2 weeks prior to randomization):
• Hematology： Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥100×10\^9/L; Hemoglobin (HGB) ≥100g/L. Renal function Cr：≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL/min; Liver function Serum total bilirubin (TBIL) ：≤ 1.5 × ULN, ≤ 3 × ULN for patients with Gilbert syndrome/metastases to liver Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)：≤ 2.5 × ULN, ≤ 5 × ULN for patients with metastases to liver Coagulation function Coagulation function Activated partial thromboplastin time (APTT) and international normalised ratio (INR)： ≤1.5×ULN
• Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;
• Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.

You may not qualify if:

• Histologically or cytologically confirmed combined small cell lung cancer,squamous cell carcinoma, neuroendocrine carcinoma,or carcinosarcoma
• Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to randomization (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
• Patients with a history of other malignant tumors within 3 years prior to randomization, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
• Patients who are known to be allergic to any component of SYS6010 or to humanized monoclonal antibody products; allergic to carboplatin, cisplatin, or pemetrexed, or have contraindications for their use;
• AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;
• 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;
• Patients who have not met the corresponding washout period requirements for the following medications or treatments should be excluded:
• Major surgery (excluding needle biopsy)：At least 4 weeks
• Small molecule targeted drugs, traditional Chinese medicines with anti-tumor indications, palliative radiation or local therapy：At least 2 weeks
• intravenous injection of antibiotics, antifungals, or antivirals：At least 2 weeks
• Investigational product and Live attenuated vaccine：At least 4 weeks
• Strong CYP3A4 inducers or inhibitors ,OATP1B1 and OATP1B3 inhibitors：At least 2 weeks
• History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization, including but not limited to:
• Presence of severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, third-degree atrioventricular block, Fridericia-corrected QT interval \> 470 ms (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate);
• History of myocardial infarction, unstable angina pectoris, aortic dissection, angioplasty, or coronary artery bypass;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Shun Lu, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SYS6010,Q3W This is a randomized, open-label, multi-center, phase III clinical study, aiming to evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy. Approximately 380 participants are planned to be enrolled, who will be randomly assigned in a 1:1 ratio to the experimental group: SYS6010, and the control group: pemetrexed + cisplatin/carboplatin. Randomization stratification factors include: presence of brain metastasis (yes or no), received third-generation EGFR TKI treatment before (yes or no)

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 15, 2025
• Study Start: March 30, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-08

Locations

CN (1)