Non-small cell lung cancer
Conditions
Interventions
ICS+TKI:Adebrelimab + Famitinib (A treatment cycle lasts for 3 weeks)
ICS+TKI+CHEMO:Adebrelimab + Famitinib + platinum-based chemotherapy (a treatment cycle lasts for 3 weekss, 2 cycles) ?Adebrelimab + Famitinib (Q3W)
Sponsors
Changzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Stage IIIb-IV non-small cell lung cancer confirmed by pathological histology or cytology (according to the 9th edition of the International Association for the Study of Cancer/American Joint Committee on Cancer Cancer Staging System); 3. PD-L1 TPS >= 1%; 4. No EGFR sensitive mutations and no ALK or ROS1 gene rearrangement; 5. No previous systemic treatment for advanced/metastatic NSCLC. Systemic treatment and/or radiotherapy can be used as part of neoadjuvant/adoptive therapy, as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease; 6. At least one measurable lesion, according to RECIST 1.1 criteria; 7. Physical condition score (ECOG PS score): 0-1; 8. Expected survival period >= 3 months; 9. Good function of major organs, that is, within 14 days before enrollment, the relevant examination indicators meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5×10*9/L; platelet count >= 100×10*9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); 10. Pregnant women must undergo a serum pregnancy test 3 days before the first administration of the drug, and the result must be negative. Male participants whose partners are pregnant women and the participants themselves are of childbearing age must agree to use effective contraceptive methods during the study and within 180 days after the last administration of the study drug; 11. Understand the study procedures and content, and voluntarily sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with other pathological types of non-small cell lung cancer, including squamous adenocarcinoma subjects and NSCLC subjects with small cell lung cancer components. 2. Subjects with known EGFR mutations or ALK positivity. 3. Subjects who have previously received PD-(L)1 or CTLA-4 treatment. 4. Subjects who have previously received anti-angiogenic drugs. 5. Subjects who have undergone surgical resection or radical radiotherapy. 6. Subjects with active central nervous system (CNS) metastases. If the CNS metastases of the subject can be adequately treated, such as maintaining clinical stability (MRI detection) for at least 4 weeks and the neurological clinical symptoms of the subject can recover to the baseline level at least 2 weeks before the first administration of the drug (excluding residual signs or symptoms related to CNS treatment), they can participate in the study. In addition, if the subject uses corticosteroid hormone therapy for related clinical symptoms, they can participate in the study after receiving a stable or gradually reduced dose of = 500 IU/ml or 1000 copies/ml) or hepatitis C (HCV-RNA above the detection limit of the analytical method); active tuberculosis or currently receiving anti-tuberculosis treatment; 10. Subjects with objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, organizing pneumonia (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia on CT examination or severe impairment of pulmonary function; 11. Subjects with cardiac function and diseases meeting one of the following conditions, which the investigator considers clinically significant and significantly abnormal and not suitable for enrollment in this study, such as complete left bundle branch block, second-degree atrioventricular block; 12-lead electrocardiogram (ECG) measurement, QTc interval for males >= 450 ms, females >= 470 ms; American Heart Association (NYHA) classification >= 3 grade heart failure or echocardiography: left ventricular ejection fraction (LVEF) 2 grade) within 4 weeks before enrollment, such as infectious complications requiring treatment, bacteremia, severe pneumonia, etc.; symptoms and signs of infection existing within 2 weeks before the first use of the drug require oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics) due to infection-induced systemic use of antibiotics; 13. Subjects diagnosed with immunodeficiency or who are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy that is not directly related to tumor treatment within 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactChong lI
Changzhou First People's Hospital
Outcome results
None listed