Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patien… (NCT06706219) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC
China50 participantsStarted 2026-05-10
Plain-language summary
This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients who voluntarily participate in this clinical study, understand the study procedures and are able to sign the informed consent form in writing;
✓. Men or women aged 18-70 years (inclusive) at the time of signing the informed consent form.
✓. ECOG PS score of 0 or 1.
✓. Histologically or cytologically confirmed stage III non-small cell lung cancer that cannot be surgically treated as determined by the investigator. Disease staging should be based on the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) NSCLC staging system, 8th edition.
✓. Ability to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug or freshly obtained. See the laboratory manual for specific requirements.
✓. Pulmonary function of at least FEV1 \> 1.0 L and FEV1% \> 40% within 3 months.
✓. Patients must have measurable target lesions examined by CT or MRI per RECIST v1.1 criteria. Tumor imaging assessments are performed within 28 days prior to the first dose.
✓. Adequate hematologic and vital organ functions, as defined by the following laboratory findings, which need to be completed within 14 days prior to the first study treatment:
Exclusion criteria
✕. Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
✕
What they're measuring
1
18m EFS rate
Timeframe: Time from the first dose treatment to 18 months
2
Surgical Conversion Rate
Timeframe: From enrollment until 8 weeks after completion of induction therapy
. Patients with EGFR gene mutations or ALK/ROS1 gene rearrangements.
✕. Prior systemic anti-tumor therapy for NSCLC (including investigational agents in clinical trials) or prior thoracic radiotherapy.
✕. History of other malignancies within 3 years prior to the first dose, except for those cured by local therapy (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).
✕. Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose; (2) History of myocardial diseases, including myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (DVT) within 3 months prior to the first dose (enrollment is permitted if DVT has been stabilized with low molecular weight heparin or equivalent therapy for ≥2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events; (4) Presence of aortic aneurysm, aortic dissection, or other major vascular diseases that are potentially life-threatening or requiring surgical intervention within 6 months prior to the first dose
✕. Uncontrolled systemic diseases as judged by the investigator, including but not limited to: (1) Poorly controlled diabetes mellitus (fasting blood glucose ≥10 mmol/L on two consecutive measurements); (2) Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg).
✕. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis at screening that cannot be excluded by imaging.
✕. Clinically significant pulmonary impairment caused by pulmonary comorbidities, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).