NSCLCPhase 3SYNSTAR-02NCT07376382
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
A Phase 3 study testing SYS6010, Osimertinib and platinum-pemetrexed in people with NSCLC, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups: Test group: SYS6010 +… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SYS6010, Osimertinib and platinum-pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 6 Jun 2029
- 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
- Age 18 ~ 75 (inclusive) years old, regardless of gender;
- Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC. For the dose escalation phase, patients must have EGFR-mutant locally advanced or metastatic NSCLC that has failed previous standard therapy, and for the dose selection phase and phase III study, patients must have EGFR-mutant locally advanced or metastatic NSCLC, which has not received EGFR-TKIs or other systemic therapy before. Patients who have received adjuvant/neoadjuvant chemotherapy may be included if disease progression occurred at least 6 months after completing treatment;
- Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations). EGFR mutation: Stage Ib: can be enrolled based on previous test results. Phase III: Take the test results of the central laboratory as the admission group;
- At least one measurable lesion confirmed by CT or MRI, as defined by RECIST v1.1 criteria;
- ECOG performance status score 0-1;
- Expected survival ≥ 3 months;
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- Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;
- Women of childbearing age had a negative blood pregnancy test within 7 days prior to the first use of study drug. Participants must agree to take effective contraceptive measures from signing the informed consent form to 7 months after the last dose, during which women are non-breastfeeding and men avoid sperm donation;
- Volunteer to participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.
Who cannot join
- Patients with meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases;
- History of other malignant tumors within 3 years prior to the first use of study drug, except for the following conditions: cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, or cervical carcinoma in situ, etc.;
- Known allergies to SYS6010 or any ingredient of Osimertinib, or to humanized monoclonal antibodies;
- Adverse events caused by prior anti-tumor therapy that have not resolved to ≤ Grade 1 (as per NCI-CTCAE v6.0), except for Grade 2 alopecia or peripheral neuropathy deemed by the investigator not to pose a safety risk;
- Use of any of the medications or treatments within the specified washout period (prior to first dose of study drug)
- History of serious cardiovascular or cerebrovascular conditions within 6 months prior to the first dose, including but not limited to:Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF > 470 ms) (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF < 50%.Stroke or other grade ≥ 3 cardiovascular/cerebrovascular events. pulmonary embolism.
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- 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;
- Severe infection within 4 weeks prior to the first dose, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis; Active systemic infections requiring antibiotics within 2 weeks prior to administration;
- Currently suffering from a skin condition requiring oral or vein administration;
- Participants with active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis or Crohn's disease) are excluded from the study. However, participants with the following conditions may be considered eligible for further screening: those with well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases unlikely to relapse even when exposed to external triggers;
- Pleural or peritoneal effusion or pericardial effusion requiring clinical intervention;
- Conditions that seriously affect gastrointestinal absorption as judged by the investigator (such as Persistent nausea, vomiting, chronic gastrointestinal diseases, gastrointestinal surgery, etc.);
- Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copy number ≥ 1 × 104 copy number/mL or ≥ 2000 IU/mL, HCV antibody positive and HCV RNA higher than the lower detection limit of the analytical method), Note: For HBsAg positive, it is recommended to start antiviral therapy before the first use of study drug, and Nucleosides analogs such as Entecavir and Tenofovir disoproxil are recommended);
- History of immunodeficiency (including positive HIV test, other acquired, congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplantation;
- Other conditions (e.g. mental illness, macular cystic edema, severe corneal diseases, uncontrolled or poorly controlled hypertension and diabetes, active bleeding, etc.) that the investigator considers inappropriate to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups:
Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）
- Conditions
- NSCLC
- Being tested
- SYS6010, Osimertinib, platinum-pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010，intravenous injection
OsimertinibDrug
Osimertinib 80mg P.O. QD
platinum-pemetrexedDrug
Pemetrexed (500 mg/m^2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m^2) every 3 weeks.
Pemetrexed (500 mg/m^2) plus cisplatin (75 mg/m^2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m^2) every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 combination | Experimental | SYS6010 + Osimertinib Receives: Drug: SYS6010; Drug: Osimertinib |
| Investigator's Choice of treatment | Active comparator | Investigator's choice of treatment means the treatment chosen by investigators to treat NSCLC including Osimertinib or Osimertinib plus platinum-pemetrexed Osimertin.ib Receives: Drug: Osimertinib; Drug: platinum-pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival(PFS) evaluated by IRC
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Measured: Up to 3.5 years
Secondary outcomes (8)
Progression Free Survival(PFS) evaluated by investigator
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Measured: Up to 2.5 years
Overall survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Measured: Up to 2.5 years
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Measured: Up to 2.5 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to 2.5 years
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Measured: Up to 2.5 years
Incidence of adverse events
Measured: Up to 2.5 years
Incidence of Anti-Drug Antibody (ADA)
Measured: Up to 2.5 years
Blood concentration of SYS6010
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion12 Dec 2026 (estimated)
- Study completion6 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- 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
- Randomized, Open-Label, Multicenter
- Masking
- None (open label)
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376382
- Sponsor's protocol ID
- SYS6010-002
- Acronym
- SYNSTAR-02
- Status last verified
- May 2026
- First submitted
- 22 Jan 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07376382
- Acronym / sponsor ID
- SYNSTAR-02 / SYS6010-002
- Conditions
- NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 6 Jun 2029 (estimated)
- First posted
- 29 Jan 2026 (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.
This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups:
Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-Label, Multicenter
| Arm | Type | Receives |
|---|---|---|
| SYS6010 combination | Experimental | Drug: SYS6010, Drug: OsimertinibSYS6010 + Osimertinib |
| Investigator's Choice of treatment | Active comparator | Drug: Osimertinib, Drug: platinum-pemetrexedInvestigator's choice of treatment means the treatment chosen by investigators to treat NSCLC including Osimertinib or Osimertinib plus platinum-pemetrexed Osimertin.ib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 ~ 75 (inclusive) years old, regardless of gender;
- Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC. For the dose escalation phase, patients must have EGFR-mutant locally advanced or metastatic NSCLC that has failed previous standard therapy, and for the dose selection phase and phase III study, patients must have EGFR-mutant locally advanced or metastatic NSCLC, which has not received EGFR-TKIs or other systemic therapy before. Patients who have received adjuvant/neoadjuvant chemotherapy may be included if disease progression occurred at least 6 months after completing treatment;
- Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations). EGFR mutation: Stage Ib: can be enrolled based on previous test results. Phase III: Take the test results of the central laboratory as the admission group;
- At least one measurable lesion confirmed by CT or MRI, as defined by RECIST v1.1 criteria;
- ECOG performance status score 0-1;
Key exclusion criteria (15 listed)
- Patients with meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases;
- History of other malignant tumors within 3 years prior to the first use of study drug, except for the following conditions: cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, or cervical carcinoma in situ, etc.;
- Known allergies to SYS6010 or any ingredient of Osimertinib, or to humanized monoclonal antibodies;
- Adverse events caused by prior anti-tumor therapy that have not resolved to ≤ Grade 1 (as per NCI-CTCAE v6.0), except for Grade 2 alopecia or peripheral neuropathy deemed by the investigator not to pose a safety risk;
- Use of any of the medications or treatments within the specified washout period (prior to first dose of study drug)
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，intravenous injection | Drug | SYS6010 combination |
| OsimertinibOsimertinib 80mg P.O. QD | Drug | Investigator's Choice of treatment, SYS6010 combination |
| platinum-pemetrexedPemetrexed (500 mg/m^2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m^2) every 3 weeks. Pemetrexed (500 mg/m^2) plus cisplatin (75 mg/m^2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m^2) every 3 weeks. | Drug | Investigator's Choice of treatment |
Primary outcome
Progression Free Survival(PFS) evaluated by IRC
Time frame: Up to 3.5 years
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
8 secondary outcomes
Progression Free Survival(PFS) evaluated by investigator
Time frame: Up to 2.5 years
Overall survival (OS)
Time frame: Up to 2.5 years
Objective Response Rate (ORR)
Time frame: Up to 2.5 years
Duration of Response (DOR)
Time frame: Up to 2.5 years
Disease Control Rate (DCR)
Time frame: Up to 2.5 years
Incidence of adverse events
Time frame: Up to 2.5 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 2.5 years
Blood concentration of SYS6010
Time frame: Up to 2.5 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 13 May 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYS6010, Osimertinib and platinum-pemetrexed in people with NSCLC, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (031169085587, 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) evaluated by IRC (time frame: Up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2026.