Non-Small Cell Lung CancerPhase 3SYNSTAR03NCT07442565
SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ
A Phase 3 study testing SYS6010 and Docetaxel in people with Non-Small Cell Lung Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- SYS6010 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 30 May 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the written ICF (Informed Consent Form); 2. Age ≥18 years, with no restriction on sex; 3. Patients with pathologically confirmed locally advanced or metastatic EGFR wild-type non-squamous non-small cell lung cancer (nsq-NSCLC). Stage IIIB or IIIC patients unsuitable for surgical resection or radical chemoradiotherapy, or Stage IV NSCLC patients. EGFR mutations (currently approved by regulatory authorities for targeted therapy) must be confirmed negative. If test results are unavailable, participants need to provide tumor tissue to undergo genetic testing.
- 4. Meet either of the following requirements regarding prior treatment for locally advanced or metastatic EGFR wild-type nsq-NSCLC:
- Driver gene-negative population must have failed only immune therapy and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
- Other driver gene-positive populations must have received and failed only targeted therapy for the driver gene and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
- 5. Have at least one measurable lesion confirmed by CT or MRI according to RECIST v1.1 criteria; 6. ECOG performance status score 0-1; 7. Expected survival ≥3 months as judged by the investigator. 8. Within 7 days before the first administration, the body organs and bone marrow function meet the requirements, defined as follows (Note: For hematological tests, participants must not have received blood component transfusion, G-CSF, TPO, TPO-RA, IL-11, or EPO within 2 weeks prior to randomization):
- ANC ≥1.5×10⁹/L
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- Platelets (PLT) ≥100×10⁹/L
- Hemoglobin (HGB) ≥100 g/L
- Serum creatinine (Cr) ≤1.5×ULN AND creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula)
- Total bilirubin (TBIL): ≤1.5×ULN for patients without liver metastases; ≤3×ULN for patients with Gilbert's syndrome or liver metastases
- ALT/AST: ≤2.5×ULN for patients without liver metastases; ≤5×ULN for patients with liver metastases
- APTT and INR ≤1.5×ULN 9. Female participants of childbearing potential must have a negative pregnancy test within 7 days before randomization. All participants must agree to use effective contraception from the time of signing the ICF until 7 months after the last dose. During this period, female participants must not be breastfeeding, and male participants must refrain from sperm donation.
Who cannot join
- Histologically or cytologically confirmed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma
- Patients with: Leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastases.
- Exception: Supratentorial and/or cerebellar metastases (excluding midbrain, pons, or medulla) are allowed if: Received local therapy (e.g., radiation/surgery) Stable for ≥2 weeks before randomization (no new lesions/enlargement on imaging, stable/improved neurological symptoms). No corticosteroids or ≤10 mg prednisone (or equivalent) daily.
- Other malignancies within 3 years before randomization, except: Cured basal/squamous cell skin cancer, superficial bladder cancer, prostate/cervical carcinoma in situ.
- Known allergies: To any component of SYS6010 or humanized monoclonal antibodies. Contraindications/hypersensitivity to docetaxel.
- Residual toxicities from prior antitumor therapy > Grade 1 (per NCI-CTCAE v6.0), except: Grade 2 alopecia or other toxicities deemed non-risky by investigators.
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- Prior treatment with topoisomerase I inhibitors (including ADCs).
- Inadequate washout periods:
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- Major surgery (excluding biopsies) within 4 weeks before first dose.
- Last antitumor therapy before first dose:
- Chemotherapy/radical radiotherapy/targeted/immunotherapy: ≥4 weeks. Small-molecule targeted drugs/TCM with antitumor claims/palliative radiotherapy/local therapy: ≥2 weeks.
- Within 2 weeks before first dose: IV antibiotics/antifungals/antivirals for the purpose of anti-infective therapy; strong CYP3A4 inducers/inhibitors; OATP1B1/1B3 inhibitors.
- Investigational drugs/live vaccines within 4 weeks before first dose. 8. Severe cardiovascular diseases within 6 months before randomization, including: Clinically significant arrhythmias (e.g., ventricular arrhythmia, AV block ≥ Grade III); QTcF >470 ms (Fridericia's formula) Myocardial infarction, unstable angina, aortic dissection, angioplasty, CABG. Heart failure ≥ NYHA Class II or LVEF <50%. Stroke or Grade ≥3 cardiovascular events. Pulmonary embolism. 9. History of ILD/non-infectious pneumonitis requiring steroids; current ILD; or suspected ILD on imaging/pulmonary function tests (severe ventilation/diffusion impairment).
- 10. Severe infections within 4 weeks before randomization (e.g., bacteremia, severe pneumonia, active TB); active infections requiring IV antibiotics within 2 weeks.
- 11. History of ulcerative colitis or Crohn's disease. 12. Pleural/pericardial effusion requiring intervention within 2 weeks. 13. Active HBV/HCV infection: HBV: HBsAg+ and/or HBcAb+ with HBV DNA ≥10⁴ copies/mL (or ≥2000 IU/mL).
- HCV: HCV Ab+ with HCV RNA above detection limit. Note: Antiviral therapy (e.g., entecavir/tenofovir) is recommended for HBsAg+ patients before randomization.
- 14. Immunodeficiency (HIV+, congenital/acquired immune disorders) or allogeneic transplant history.
- 15. Other conditions deemed ineligible by investigators (e.g., uncontrolled psychiatric disorders, hypertension/diabetes).
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 Study Comparing SYS6010 With Docetaxel in Patients With Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Who Have Failed Standard Therapy
This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.
Read the detailed description
This is a randomized, open-label, multicenter, Phase III clinical study designed to evaluate the efficacy and safety of SYS6010 compared with docetaxel in participants with locally advanced or metastatic EGFR wild-type nsq-NSCLC who have failed standard therapy.
Approximately 506 participants will be enrolled and randomized 1:1 to receive either SYS6010 or docetaxel. Randomization will be stratified by: (1) brain metastases (yes vs no) and (2) EGFR high expression (yes vs no). EGFR protein expression will be assessed by immunohistochemistry (IHC).
Key eligibility criteria include: age ≥18 years; histologically or cytologically confirmed locally advanced or metastatic nsq-NSCLC; and EGFR mutation negative confirmed for the EGFR wild-type population. For participants who are driver gene-negative, prior therapy must have included immunotherapy and platinum-based chemotherapy ± anti-angiogenic therapy with documented treatment failure. For participants who are driver gene-positive, prior therapy must have included appropriate targeted therapy for the driver alteration and platinum-based chemotherapy, with treatment failure.
The study includes a screening/baseline period, treatment period, safety follow-up (30 days after the last dose), PFS follow-up, and survival follow-up.
Study Treatments:
SYS6010: intravenous infusion 4.5 mg/kg Q3W. Docetaxel: intravenous infusion 75 mg/m² Q3W. Treatment will continue until meeting any protocol-defined treatment discontinuation criteria.
Dose modifications may include dose interruption, dose reduction, and permanent discontinuation.
Safety Assessments: Safety will be assessed from informed consent through 30 days after the last dose, including collection of all adverse events (AEs), clinical symptoms, vital signs, and laboratory abnormalities, and assessment of relationship to study treatment. Safety-related examinations (e.g., physical examination, ECOG performance status, laboratory tests) will be performed during screening/baseline and throughout treatment.
Efficacy Assessments: Tumor response will be evaluated per RECIST v1.1. The first post-randomization tumor assessment will occur at 6 weeks (+7 days). Subsequent assessments will be performed every 6 weeks (±7 days) through Week 54 (excluding the first assessment), and every 12 weeks (±7 days) from Week 55 onward, and at the end of treatment if no assessment has been performed within the prior 4 weeks. Participants who discontinue treatment prior to disease progression will enter PFS follow-up until disease progression, initiation of new anticancer therapy, death, loss to follow-up, or withdrawal (whichever occurs first).
Pharmacokinetics and Immunogenicity: Participants in the SYS6010 arm will undergo blood sampling for pharmacokinetics (PK) and immunogenicity assessments during the study.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SYS6010, Docetaxel
- 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, intravenous injection
DocetaxelDrug
Docetaxel, intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 | Experimental | SYS6010 Receives: Drug: SYS6010 |
| Docetaxel | Active comparator | Docetaxel Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by IRC per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Measured: Up to approximately 22 months
OS (Overall Survival) in the overall population
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 approximately 39 months
Secondary outcomes (10)
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 IRC per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Measured: Up to approximately 22 months
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 approximately 22 months
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 approximately 22 months
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Measured: Up to approximately 22 months
Incidence of adverse events
Measured: Up to approximately 21 months
Quality of life assessed by EORTC QLQ-C30
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0-100 scale. For Global Health Status/QoL and functional scales, higher scores indicate better health status/functioning; for symptom scales/items, higher scores indicate worse symptom burden.
Measured: Up to approximately 21 months
Quality of life assessed by EORTC QLQ-LC13
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13). Scores are linearly transformed to a 0-100 scale, and higher scores indicate worse lung cancer-related symptoms (greater symptom burden).
Measured: Up to approximately 21 months
Anti-SYS6010 antibodies (ADA）
Incidence of SYS6010 anti-drug antibodies
Measured: Up to approximately 21 months
EGFR protein expression lever (IHC)
EGFR protein expression assessed by immunohistochemistry (IHC)
Measured: Up to approximately 21 months
Exploratory Genomic Analysis by Next-Generation Sequencing (NGS)
Tumor samples will be assessed by next-generation sequencing (NGS) to characterize genomic alterations.
Measured: Up to approximately 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Participants in this trial will be randomly assigned to one of two groups.
- Masking
- None (open label)
- Enrolment
- 506 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
- NCT07442565
- Sponsor's protocol ID
- SYS6010-020
- Acronym
- SYNSTAR03
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase III Study Comparing SYS6010 With Docetaxel in Patients With Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT07442565
- Acronym / sponsor ID
- SYNSTAR03 / SYS6010-020
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 2 Mar 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 is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.
Detailed description
This is a randomized, open-label, multicenter, Phase III clinical study designed to evaluate the efficacy and safety of SYS6010 compared with docetaxel in participants with locally advanced or metastatic EGFR wild-type nsq-NSCLC who have failed standard therapy.
Approximately 506 participants will be enrolled and randomized 1:1 to receive either SYS6010 or docetaxel. Randomization will be stratified by: (1) brain metastases (yes vs no) and (2) EGFR high expression (yes vs no). EGFR protein expression will be assessed by immunohistochemistry (IHC).
Key eligibility criteria include: age ≥18 years; histologically or cytologically confirmed locally advanced or metastatic nsq-NSCLC; and EGFR mutation negative confirmed for the EGFR wild-type population. For participants who are driver gene-negative, prior therapy must have included immunotherapy and platinum-based chemotherapy ± anti-angiogenic therapy with documented treatment failure. For participants who are driver gene-positive, prior therapy must have included appropriate targeted therapy for the driver alteration and platinum-based chemotherapy, with treatment failure.
The study includes a screening/baseline period, treatment period, safety follow-up (30 days after the last dose), PFS follow-up, and survival follow-up.
Study Treatments:
SYS6010: intravenous infusion 4.5 mg/kg Q3W. Docetaxel: intravenous infusion 75 mg/m² Q3W. Treatment will continue until meeting any protocol-defined treatment discontinuation criteria.
Dose modifications may include dose interruption, dose reduction, and permanent discontinuation.
Safety Assessments: Safety will be assessed from informed consent through 30 days after the last dose, including collection of all adverse events (AEs), clinical symptoms, vital signs, and laboratory abnormalities, and assessment of relationship to study treatment. Safety-related examinations (e.g., physical examination, ECOG performance status, laboratory tests) will be performed during screening/baseline and throughout treatment.
Efficacy Assessments: Tumor response will be evaluated per RECIST v1.1. The first post-randomization tumor assessment will occur at 6 weeks (+7 days). Subsequent assessments will be performed every 6 weeks (±7 days) through Week 54 (excluding the first assessment), and every 12 weeks (±7 days) from Week 55 onward, and at the end of treatment if no assessment has been performed within the prior 4 weeks. Participants who discontinue treatment prior to disease progression will enter PFS follow-up until disease progression, initiation of new anticancer therapy, death, loss to follow-up, or withdrawal (whichever occurs first).
Pharmacokinetics and Immunogenicity: Participants in the SYS6010 arm will undergo blood sampling for pharmacokinetics (PK) and immunogenicity assessments during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in this trial will be randomly assigned to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| SYS6010 | Experimental | Drug: SYS6010SYS6010 |
| Docetaxel | Active comparator | Drug: DocetaxelDocetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the written ICF (Informed Consent Form); 2. Age ≥18 years, with no restriction on sex; 3. Patients with pathologically confirmed locally advanced or metastatic EGFR wild-type non-squamous non-small cell lung cancer (nsq-NSCLC). Stage IIIB or IIIC patients unsuitable for surgical resection or radical chemoradiotherapy, or Stage IV NSCLC patients. EGFR mutations (currently approved by regulatory authorities for targeted therapy) must be confirmed negative. If test results are unavailable, participants need to provide tumor tissue to undergo genetic testing.
- 4. Meet either of the following requirements regarding prior treatment for locally advanced or metastatic EGFR wild-type nsq-NSCLC:
- Driver gene-negative population must have failed only immune therapy and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
- Other driver gene-positive populations must have received and failed only targeted therapy for the driver gene and platinum-based chemotherapy ± anti-angiogenic therapy (limited to first-line regimens approved by regulatory authorities).
- 5. Have at least one measurable lesion confirmed by CT or MRI according to RECIST v1.1 criteria; 6. ECOG performance status score 0-1; 7. Expected survival ≥3 months as judged by the investigator. 8. Within 7 days before the first administration, the body organs and bone marrow function meet the requirements, defined as follows (Note: For hematological tests, participants must not have received blood component transfusion, G-CSF, TPO, TPO-RA, IL-11, or EPO within 2 weeks prior to randomization):
Key exclusion criteria (19 listed)
- Exception: Supratentorial and/or cerebellar metastases (excluding midbrain, pons, or medulla) are allowed if: Received local therapy (e.g., radiation/surgery) Stable for ≥2 weeks before randomization (no new lesions/enlargement on imaging, stable/improved neurological symptoms). No corticosteroids or ≤10 mg prednisone (or equivalent) daily.
- <!-- -->
- Chemotherapy/radical radiotherapy/targeted/immunotherapy: ≥4 weeks. Small-molecule targeted drugs/TCM with antitumor claims/palliative radiotherapy/local therapy: ≥2 weeks.
- 10. Severe infections within 4 weeks before randomization (e.g., bacteremia, severe pneumonia, active TB); active infections requiring IV antibiotics within 2 weeks.
- 11. History of ulcerative colitis or Crohn's disease. 12. Pleural/pericardial effusion requiring intervention within 2 weeks. 13. Active HBV/HCV infection: HBV: HBsAg+ and/or HBcAb+ with HBV DNA ≥10⁴ copies/mL (or ≥2000 IU/mL).
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 |
| DocetaxelDocetaxel, intravenous injection | Drug | Docetaxel |
Primary outcome
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.
Time frame: Up to approximately 22 months
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by IRC per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
OS (Overall Survival) in the overall population
Time frame: Up to approximately 39 months
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.
10 secondary outcomes
Progression Free Survival (PFS) evaluated by investigator
Time frame: Up to approximately 22 months
Objective Response Rate (ORR)
Time frame: Up to approximately 22 months
Duration of Response (DOR)
Time frame: Up to approximately 22 months
Disease Control Rate (DCR)
Time frame: Up to approximately 22 months
Incidence of adverse events
Time frame: Up to approximately 21 months
Quality of life assessed by EORTC QLQ-C30
Time frame: Up to approximately 21 months
Quality of life assessed by EORTC QLQ-LC13
Time frame: Up to approximately 21 months
Anti-SYS6010 antibodies (ADA）
Time frame: Up to approximately 21 months
EGFR protein expression lever (IHC)
Time frame: Up to approximately 21 months
Exploratory Genomic Analysis by Next-Generation Sequencing (NGS)
Time frame: Up to approximately 21 months
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 4 Mar 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 and Docetaxel in people with Non-Small Cell Lung Cancer, 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 12 inclusion and 19 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 4 Mar 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?
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population. (time frame: Up to approximately 22 months). The study lists 2 primary outcomes in all. 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 4 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.