NSCLC
Conditions
Interventions
Intervention:When recant satuzumab and sintilimab are given on the same day, drug therapy should be given sequentially, with sintilimab given first, at least 60 minutes apart, and then sartolizumab gi
Sponsors
Shapingba District People's Hospital, Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 2. Age >=18 years old and =3 months; 5. Patients with non-small cell lung cancer confirmed by pathological histology or cytology, and the initial unresectable clinical stage is stage III (according to the 8th edition of the TNM stage of lung cancer by the International Union Against Cancer and the American Joint Committee on Cancer), and the initial untangential definition (meeting any of the following criteria): (1) Patients whose tumors invade important structures such as large blood vessels, trachea or main bronchus, and whose preoperative evaluation determines that there is a chance of resection for the purpose of cure after de-escalation of induction therapy; (2) Patients with clinically confirmed lymph nodes with multi-station metastasis or massive fusion, and who can tolerate and undergo hilar and mediastinal lymph node dissection after de-escalation of induction therapy are judged to be preoperatively evaluated; (3) The preoperative evaluation concluded that even if pneumonectomy was performed, especially the right pneumonectomy, there was a possibility that R0 resection could not be performed; 6. Negative for EGFR sensitive mutations, negative for ALK and ROS1 fusions confirmed by pathological histology or cytology; For subjects with non-squamous cell carcinoma (including NSCLC with unclear pathological type), tumor tissue-based EGFR, ALK, ROS1 test results must be provided. If the translocation status of EGFR mutation, ALK, and ROS1 genes is unknown, EGFR, ALK, and ROS1 gene mutation testing must be performed before enrollment; For subjects with squamous non-small cell lung cancer, testing at screening is not required if EGFR mutation, ALK, ROS1 gene status is unknown; 7. Have not received any form of anti-tumor therapy in the past. 8. At least one measurable lesion according to RECIST v1.1 (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions >=10mm, and the short diameter of CT scan of lymph node lesions >=15mm), and suitable for repeated accurate measurements; 9. Determination of good organ function by the following requirements: (1) Lung ventilation function test, FEV1>=1.5L, or predicted FEV1>=800ml after lobe/pneumoresection; (2) Hematology (no use of any blood components and cell growth factor supportive therapy within 7 days before starting study treatment): i. Absolute neutrophil ANC>=1.5×10^9/L; ii. Platelet count>=100×109/L; iii. Hemoglobin >=90 g/L; (3) Kidney: i. Serum creatinine (Cr) =50 mL/min; *CrCl will be calculated using the Cockcroft-Gault formula; CrCl (mL/min) = {(140-age) × body weight (kg)×F}/(SCr (mg/dL) × 72); F=1 for males and F=0.85 for females, and SCr=serum creatinine ii. Urine protein =28 g/L; (5) Coagulation function: international normalized ratio (INR), and partial prothrombin time (PTT) or
Exclusion criteria
Exclusion criteria: 1. Patients with large cell carcinoma and mixed cell lung cancer, mixed with small cell lung cancer ingredients; 2. Presence of metastatic disease; 3. Have undergone any systemic or local anti-tumor therapy for NSCLC, including cytotoxic drug therapy, immunodrug therapy, radiotherapy, investigational therapy, biologics, small molecule targeted therapy, etc.; 4. Concurrent enrollment in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time of first administration more than 4 weeks from the last dose of the previous clinical study or more than 5 half-lives of the investigational drug, whichever is shorter); 5. Palliative local treatment for non-target lesions within 2 weeks before the first dose; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymopeptide, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first dose; Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose; Past medical history and comorbidities: 6. Other malignancies other than NSCLC within 5 years prior to the first dose of medication (subjects with other malignancies that have been cured by local therapy are allowed to be included, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ); 7. Active autoimmune disease requiring systemic treatment (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment; 8. Previous history of severe dry eye disease, severe meibomian gland disease (MBG) and/or blepharitis, corneal lesions that cause the subject's cornea to be incurable or cure delayed, and macular degeneration. 9. Daily activities requiring oxygen, symptomatic pleural effusion (less than 90% oxygen saturation); 10. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association NYHA classification<=2) or vascular disease (such as aortic aneurysm with risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia, etc.); 11. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to the first dose; 12. Any arterial thromboembolic event, venous thromboembolic event of grade 3 and above specified by NCI CTCAE 5.0 within 6 months prior to the first dose, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; 13. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before the first dose; 14. Vaccination with a live vaccine or live attenuated vaccine within 4 weeks prior to the first dose, or planning to receive a live vaccine or live attenuated vaccine during the study, the use of an inactivated vaccine is permitted; 15. Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospita
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactPu Zhou
Shapingba District People's Hospital, Chongqing
Outcome results
None listed