Resectable non-small cell lung cancer
Conditions
Interventions
Experimental group:Sacituzumab Tirumotecan(SKB-264) in Combination with Tislelizumab
Sponsors
Department of Thoracic Surgery, Nanfang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following criteria before they can be enrolled in this study: 1. Voluntary signing of written informed consent. (1) Subjects must sign and date the IRB/IEC-approved informed consent form according to the guidelines of the competent authorities and research institutions. Informed consent must be signed before any protocol-related procedures (which are not part of the subject's routine medical care) are carried out; (2) Subjects must be willing and able to abide by the visit, treatment plan, laboratory examination and other requirements of the study stipulated in the schedule; 2. The age at the time of joining the group is >=18 years old and =3 months; 5. Patients with squamous or non-squamous non-small cell lung cancer diagnosed by histopathology or cytology, and the resectable clinical stage is stage II-IIIB (T3N2) (according to TNM staging of lung cancer in the 8th edition of the Joint Commission on Cancer of union for international cancer control and the United States); 6. It was confirmed by histopathology or cytology that EGFR sensitive mutation was negative, ALK and fusion were negative; (1) For non-squamous cell carcinoma subjects (including NSCLC with unclear pathological type), EGFR, ALK and test results based on tumor tissues must be provided. If the status of EGFR mutation, ALK and gene translocation is unknown, EGFR, ALK and gene mutation must be detected before joining the group; (2) For the subjects with squamous non-small cell lung cancer, if the EGFR mutation, ALK and gene status are unknown, it is not required to be tested during screening; 7. Never received any form of anti-tumor treatment before; 8. According to RECIST v1.1, there is at least one measurable lesion (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesion is >=10mm, and the short diameter of CT scan of lymph node lesion is =15mm), and it is suitable for repeated and accurate measurement; 9. The subject must have sufficient cardiopulmonary function for the anticipated radical pneumonectomy; 10. Determine good organ function through the following requirements: (1) pulmonary ventilation function test, FEV1>=1.5L, or FEV1>=800ml; after lobectomy/pneumonectomy; (2) Hematology (no blood components and cell growth factors were used to support the treatment within 7 days before the start of the study): 1). The absolute value of neutrophils ANC >= 1.5× 10^9/L; 2). Platelet count >= 100× 10^9/L; 3). Hemoglobin >= 90 g/L. (3). Kidney: 1). Serum creatinine (Cr)= 50 ml/min; * Cockcroft-Gault formula will be used to calculate CrCl;; CrCl (mL/min) = {(140- age )× body weight (kg )× f}/(SCR (mg/dl )× 72); Among them, male F=1 and female f = 0.85; SCr= serum creatinine 2). Urine protein = 28 g/L; (5) Coagulation function: International standardized ratio (INR), and partial prothrombin time (PTT) or activated partial thromboplastin time (APTT)<= 1.
Exclusion criteria
Exclusion criteria: Tumor-related characteristics and treatment; 1. Patients with large cell carcinoma and mixed cell lung cancer, mixed with small cell lung cancer components; 2. There are locally advanced unresectable or metastatic diseases; 3. Any systemic or local anti-tumor therapy for NSCLC, including cytotoxic drug therapy, immunotherapy, radiotherapy, experimental therapy, biological agents, small molecule targeted therapy, etc.; 4. Join another clinical study at the same time, unless it is a non-intervention clinical study or a follow-up period of an intervention study (defined as the time when the first medication is more than 4 weeks from the last medication of the previous clinical study or more than 5 half-lives of the research drug, whichever is shorter); 5. Palliative local treatment was given to non-target lesions within 2 weeks before the first administration; Non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) was received within 2 weeks before the first administration; Have received Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 1 week before the first administration; Past medical history and concurrent diseases: 6. Suffering from other malignant tumors except NSCLC within 3 years before the first medication; (1). It is allowed to include subjects with other malignant tumors that have been cured by local treatment, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ; 7. Suffering from active autoimmune diseases requiring systematic treatment within 2 years before taking the first drug (such as treatment with drugs to improve the condition, corticosteroids and immunosuppressants) (excluding irAE caused by using PD-1/L1 inhibitors). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not considered as a systematic treatment; 8. There is a history of major diseases within 1 year before the first medication, specifically: (1) There are unstable angina pectoris, myocardial infarction, congestive heart failure (NYHA classification of new york Heart Association >=2) or vascular diseases (such as aortic aneurysm with rupture risk), or other heart damage (such as poorly controlled arrhythmia, myocardial ischemia, etc.) that may affect the safety evaluation of the study drug within 12 months before the first administration; (2) There was a history of esophageal and gastric varices, severe ulcer, unhealed wound, abdominal fistula, abdominal abscess or acute gastrointestinal bleeding within 6 months before the first administration; (3) There have been any arterial thromboembolism events, venous thromboembolism events of grade 3 or above specified in NCI CTCAE 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy within 6 months before the first administration; (4) Acute exacerbation of chronic obstructive pulmonary disease occurred within 4 weeks before the first administration; 9. Have a history of gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition) and extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea) within 6 months before the first administratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological response;24 months disease-free survival rate;Objective remission rate;R0 resection rate;Tumor decline rate;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactCai kaican
Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University,
Outcome results
None listed