About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- Sacituzumab tirumotecan plus toripalimab