EGFR-mutated Locally Advanced or Metastatic NSCLCPhase 3NCT06927986

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

A Phase 3 study testing SYS6010, Pemetrexed and Cisplatin in people with EGFR-mutated Locally Advanced or Metastatic NSCLC, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: EGFR-mutated Locally Advanced or Metastatic NSCLC
What is being tested?: SYS6010, Pemetrexed and Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 380 participants
Where: 1 siteChina
Study dates: 30 Mar 2025to 30 Aug 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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;
NYHA class II or higher cardiac failure, LVEF<50% at screening;
Stroke or other Grade 3 or higher cardiovascular and cerebrovascular events;
Pulmonary embolism;
Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.
Patients who have a history of ILD/non-infectious pneumonitis treated with corticosteroids in the past, currently have ILD/non-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD/non-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and/or decreased diffusion capacity;
Presence of severe infections within 4 weeks prior to randomization, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to randomization;
Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;
History of ulcerative colitis or Crohn's disease;
Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;
Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 copies/mL or ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before randomization, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;
History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;
Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Lu Shun, Ph.D, 2200000-3123, shunlu_shchest@sina.com
Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment

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)

Read the detailed description

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.

This study implemented a hierarchical testing strategy to control the overall Type I error at a one-sided alpha level of 0.025. If the null hypothesis for PFS was rejected, the full alpha (0.025) was recycled for OS analysis.

Conditions: EGFR-mutated Locally Advanced or Metastatic NSCLC
Being tested: SYS6010, Pemetrexed, Cisplatin, Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SYS6010Drug
SYS6010,Q3W
PemetrexedDrug
Pemetrexed injection 500 mg/m^2 administered via intravenous infusion，Q3W
CisplatinDrug
Cisplatin 75 mg/m^2 administered via intravenous infusion，Q3W
CarboplatinDrug
Carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Study groups in NCT06927986
Study group	Role	What they receive
SYS6010	Experimental	Not described Receives: 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 Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to approximately 1.5 years

Secondary outcomes (12)

Investigator-assessed PFS
Defined as the time from randomisation until the date of objective disease progression or death was assessed by investigator according to RECIST 1.1
Measured: Up to approximately 1.5 years
Disease Control Rate (DCR)
Defined as the percentage of subjects who have a best overall response of CR or PR or SD based on IRC and investigator according to RECIST 1.1
Measured: Up to approximately 2 years
Objective response rate (ORR)
: Defined as the proportion of patients with response (including CR and PR) assessed by the investigator and the IRC according to RECIST v1.1.
Measured: Up to approximately 1.5 years
Overall Survival (OS)
Defined as the time from randomization until death from any cause
Measured: Up to approximately 2 years
Incidence of adverse events (AEs)
AEs graded by CTCAE version 5.0
Measured: Up to approximately 2 years
Serious adverse events (SAEs)
SAEs graded by CTCAE version 5.0
Measured: Up to approximately 2 years
EORTC QLQ-LC13 questionnaire
EORTC QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis.
Measured: Up to approximately 2 years
EORTC QLQ-30 questionnaire
EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions.
Measured: Up to approximately 2 years
Plasma concentrations of toxin-bound antibodies
Tests are conducted after single and continuous administration of SYS6010.
Measured: Up to approximately 2 years
Plasma concentrations of total antibodies
Tests are conducted after single and continuous administration of SYS6010.
Measured: Up to approximately 2 years
Plasma concentrations of free toxin (JS-1)
Tests are conducted after single and continuous administration of SYS6010.
Measured: Up to approximately 2 years
anti-SYS6010 antibodies (ADA)
Incidence of SYS6010 anti-drug antibodies
Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202530 Aug 2026

First posted15 Apr 2025
Study start30 Mar 2025
Primary completion30 Jul 2026 (estimated)
Study completion30 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EGFR-mutated Locally Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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)
Masking: None (open label)
Enrolment: 380 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06927986
Sponsor's protocol ID: SYS6010-011
Status last verified: Aug 2025
First submitted: 12 Mar 2025
Last updated: 1 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment
ClinicalTrials.gov ID: NCT06927986
Acronym / sponsor ID: SYS6010-011
Conditions: EGFR-mutated Locally Advanced or Metastatic NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 380 participants (estimated)
Lead sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
Study start: 30 Mar 2025 (actual)
Primary completion: 30 Jul 2026 (estimated)
Study completion: 30 Aug 2026 (estimated)
First posted: 15 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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)

Arm	Type	Receives
SYS6010	Experimental	Drug: SYS6010
Platinum-containing chemotherapy	Active comparator	Drug: Pemetrexed, Drug: Cisplatin, Drug: CarboplatinPemetrexed injection 500 mg/m^2 + cisplatin 75 mg/m^2 or carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (27 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYS6010SYS6010,Q3W	Drug	SYS6010
PemetrexedPemetrexed injection 500 mg/m^2 administered via intravenous infusion，Q3W	Drug	Platinum-containing chemotherapy
CisplatinCisplatin 75 mg/m^2 administered via intravenous infusion，Q3W	Drug	Platinum-containing chemotherapy
CarboplatinCarboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W	Drug	Platinum-containing chemotherapy

Primary outcome

Progression-free survival (PFS) assessed by independent review committee (IRC)
Time frame: Up to approximately 1.5 years
Defined as the time from randomisation until the date of objective disease progression or death was assessed by IRC according to RECIST 1.1

12 secondary outcomes

Investigator-assessed PFS
Time frame: Up to approximately 1.5 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Time frame: Up to approximately 1.5 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Incidence of adverse events (AEs)
Time frame: Up to approximately 2 years
Serious adverse events (SAEs)
Time frame: Up to approximately 2 years
EORTC QLQ-LC13 questionnaire
Time frame: Up to approximately 2 years
EORTC QLQ-30 questionnaire
Time frame: Up to approximately 2 years
Plasma concentrations of toxin-bound antibodies
Time frame: Up to approximately 2 years
Plasma concentrations of total antibodies
Time frame: Up to approximately 2 years
Plasma concentrations of free toxin (JS-1)
Time frame: Up to approximately 2 years
anti-SYS6010 antibodies (ADA)
Time frame: Up to approximately 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

Shun Lu, Doctor principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYS6010, Pemetrexed and Cisplatin in people with EGFR-mutated Locally Advanced or Metastatic NSCLC, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by independent review committee (IRC) (time frame: Up to approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06927986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.