SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ (NCT07442565) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ
506 participantsStarted 2026-03-10
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. ANC ≥1.5×10⁹/L
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.
. 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
Exclusion criteria
. 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.
. 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.
. Prior treatment with topoisomerase I inhibitors (including ADCs).
. Inadequate washout periods:
. Major surgery (excluding biopsies) within 4 weeks before first dose.