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
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.
Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
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.).
Single group
Sacituzumab tirumotecan plus toripalimab
DrugParticipants meeting the inclusion criteria will receive toripalimab (240 mg, IV) + SKB264 (4mg/kg, IV) for 12 weeks as induction therapy. Patients who undergo surgical resection will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for up to 13 cycles. Patients who receive definitive concurrent chemoradiotherapy will receive toripalimab 240 mg intravenously every 3 weeks (Q3W) for a maximum duration of 1 year.
18m EFS rate
18-month progression-free survival (PFS) rate
Surgical Conversion Rate
The Surgical Resection Rate is defined as the proportion of subjects who successfully undergo surgical resection after completing the induction therapy phase
Event-free survival (EFS)
Defined as the time from the first dose treatment to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
R0 surgical resection rate
No residual ratio under the microscope after surgical resection
Complete Response (pCR) rate
Defined as the absence of active tumors in lesions at the time of surgical resection of primary tumors.
Major Pathological Response (MPR) rate
Defined as the incidence of ≤10% active tumors in lesions at the time of surgical resection of primary tumors.
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This trial is not recruiting at the moment. You can still explore other options:
