advanced or metastatic NSCLC
Conditions
Interventions
Queue 1:After the 2nd cycle of Adebelimab, combined with the 2nd cycle of Ivarmacitinib, and after the maintenance treatment of Adebrelimab
Queue 2:After 2 cycles of adebelimab combined with platinum-containing double-drug chemotherapy, Adebelimab combined with emacetinib 2 cycles, and then Adebel
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign an informed consent form; 2. Age >=18 years old, both male and female; 3. According to the 9th edition of the International Lung Cancer Research Association (UICC) and the Joint Committee of American Cancer Classification (AJCC), the 9th edition of Lung Cancer TNM stage is IIIB-IIIC/IV stage of non-operable or radical radiotherapy confirmed by histological or cytology. 4. I have never received systemic treatment for localised late/metastatic NSCLC in the past. Chemotherapy and/or radiotherapy are allowed to be used as part of the new adjuvant/adjuvant treatment, requiring that the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease. 5. Within 4 weeks before joining the group, imaging evaluation (CT or MRI), at least one measurable target foci (according to the RECIST v1.1 standard); 6. Subjects need to be tested for PD-L1 TPS, Queue 1: PD-L1 TPS >=50%,Queue 2:PD-L1 TPS =12 weeks; 9. The functions of important organs meet the following requirements: (1) blood routine: white blood cell count (WBC) >=3.0×10^9/L; absolute neutrophil count (ANC) >=1.5×10^9/L; platelet (PLT) >=100×10^9/L; haemoglobin content (HGB) >=9.0 g/dL (no corresponding blood transfusion, leucocyte rise and other supportive treatment within 7 days); (2) Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) =30g/L, alkaline phosphatase (ALP) =50 mL/min (using Cockcroft/Gault formula); urine protein (UPRO) <(++), or 24-hour urine protein <1.0 g; (4) Coagulation function: international standardised ratio (INR) <=1.5 and activated partial prothrombin activation time (APTT) <=1.5 times ULN; If the patient is receiving anticoagulant treatment, as long as PT or APTT are within the expected treatment range of anticoagulants, please refer to the relevant drug instructions for details; (5) Thyroid-stimulating hormone (TSH) <= normal upper limit (ULN), if abnormal, T3 and T4 levels should be examined, and T3 and T4 levels are normal can be selected; 10. Female patients with non-surgical sterilisation or childbearing age must take a serum pregnancy test within 7 days before the first use of the drug, and the result is negative; and must be non-lactating. Female patients of childbearing age or male patients whose partners are women of childbearing age must agree to use an efficient method of contraception within 6 months after the study period and the last time the research drug is given.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed that NSCLC is mixed with small cell lung cancer components; 2. Known EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK rearraing, ROS1/RET fusion positive, MET 14 exon jump mutation of NSCLC; 3. Patients who have previously received anti-PD-(L)1, CTLA-4 treatment or other immune checkpoint inhibitors, JAK inhibitors; 4. Active brain metastasis or meningeal metastasis. However, the following patients are allowed to enter the group: those who have received brain or meningeal metastasis treatment (radiotherapy or surgery) in the past, such as those who have been stable for at least 2 weeks before entering the group, and have stopped systemic hormone treatment (prednisone dose =500 IU/ml or 1000 copies/ml) or viral hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower detection limit of the analysis method); active tuberculosis or currently receiving anti-tuberculosis treatment; 8. Past idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, tissue pneumonia (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia in CT examination or radioactive pneumonia that requires steroid treatment; 9. Heart function and disease meet one of the following conditions. The researchers believe that it is clinical significance and is obviously abnormal and not suitable for the study of this study, including but not limited to complete left bundle branch conduction abnormalities, II-degree atrioventricular conduction block; 12-lead electrocardiogram (ECG) measurement, QTc interval >=450ms in men, women >=470ms; New York Cardiology Society (NYHA) grade >=3 heart failure or cardiac color ultrasound examination: left ventricular blood ejection fraction (LVEF) 2 level) occurred within 4 weeks before entering the group, infection complications, bacteremia, severe pneumonia, etc. that need treatment; symptoms and signs of infection within 2 weeks before the first use of the drug require oral or intravenous antibiotic treatment (excluding preventive use of antibiotics); 11. <=5 years before joining the group with other malignant tumors, except for cervical in situ cancer, basal cell or squamous cell skin cancer, local prostate cancer after radical treatment, and catheter in situ can
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS ;Duration of response, DoR;Progression free survival, PFS;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactHuijuan Wang
Henan Cancer Hospital
Outcome results
None listed