Lung cancer
Conditions
Interventions
Treatment group:Cardanilide combined with chemotherapy
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Sign written informed consent before implementing any testing related processes; 2) Age = 18 years old; 3) The expected lifespan exceeds 3 months; 4) Researchers have confirmed the presence of at least one measurable lesion according to the RECIST 1.1 standard; 5) EGFR/ALK wild-type; The subject must be able to provide previous driving gene reports based on tissue or blood testing, and the test results show that EGFR sensitive mutations, ALK rearrangement or fusion, and ROS1 fusion are all negative; Or there may be a certain type of driving gene positive but the targeted drug is not accessible or has contraindications, or the subject refuses to use it. If the subject does not have a driver gene test report, tumor samples (archived or fresh, primary or metastatic) or blood samples need to be collected before enrollment to confirm a negative driver gene test (in a local or central laboratory); 6) According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification of the United States, 8th edition of the TNM staging classification for lung cancer, patients with locally advanced (IIIB/IIIC), metastatic or recurrent (IV) NSCLC who are confirmed by histology or cytology to be inoperable and unable to undergo radical radiotherapy and chemotherapy; 7) PD-L1 expression TPS<1%; 8) The Eastern Cancer Collaborative Group (ECOG) has a physical fitness score of 0-2; 9) Has not received any systematic anti-tumor treatment for advanced/metastatic diseases in the past; For patients who have previously received platinum containing adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or radical radiotherapy for advanced diseases, if the disease progression occurs more than 6 months after the end of the last treatment, they can participate in this study; 10) Hematology is fully functional, defined as an absolute count of neutrophils = 1.5 × 109/L, platelet count = 100 × 109/L, hemoglobin = 90g/L (no blood transfusion history within 7 days); 11) Adequate liver function is defined as all patients with total bilirubin levels = 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 times the ULN, or for patients with liver metastasis, AST and ALT levels = 5 times the ULN; 12) Adequate renal function, defined as serum creatinine = 1.5 times ULN; 13) Adequate coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; If the subject is receiving anticoagulant treatment, as long as the INR/PT is within the range of anticoagulant drugs proposed; 14) Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Reliable contraceptive measures (such as intrauterine devices, contraceptives, and condoms) should be used within 30 days of the start and end of the experiment; Male subjects of childbearing age should use condoms for contraception during the trial period and within 30 days after the end of the trial;
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1) Currently participating in interventional clinical research and treatment; 2) Previously received the following therapies: anti PD-1, anti PD-L1, or anti PD-L2 drugs, or drugs targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137); 3) Known to have allergic reactions to the active ingredients and/or any excipients of cardunizumab; 4) There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis that require clinical intervention; 5) Patients with clinically uncontrollable pleural/abdominal effusion (those who do not require drainage of the effusion or do not have a significant increase in effusion after stopping drainage for 3 days can be enrolled); 6) Tumors compress important organs around them (such as the esophagus) and accompanied by related symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc; 7) Severe comorbidities such as a history of severe lung or heart disease, with any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. Have a history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implantable venous infusion port or catheter derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism); 8) A history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barre's syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune hypothyroidism who receive stable dose thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes who have been controlled after receiving a stable insulin treatment program are eligible to participate in this study; 9) Active systemic infections, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, as well as TB tests conducted according to local medical practices), hepatitis B (known to be positive for HBV surface antigen (HBsAg) and HBV DNA = 1000cps/ml or its lower reference value), hepatitis C or human immunodeficiency virus (HIV antibody positive); 10) There are known cases of mental illness or substance abuse that may have an impact on compliance with the trial requirements; 11) There may be medical history, illness, treatment, or laboratory abnormal results that may interfere with the experimental results, hinder the full participation of the subjects in the study, or the researchers believe that participating in the study is not in the best interests of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year PFS rate;OS;PFS;DCR;DOR; | — |
Countries
CHINA
Contacts
Public ContactShi Qinming
Anhui Chest Hospital
Outcome results
None listed