Non-Small Cell Lung Cancer
Conditions
Interventions
Trial group 1:Combination of TQB3454 with Sintilimab and Docetaxel
Sponsors
shanghai pulmonary hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Obtain written informed consent before implementing any trial-related procedures. 2.Age = 18 years old. 3.Patients with locally advanced (stage III B/III C), metastatic, or recurrent (stage IV) NSCLC confirmed histologically or cytologically, who are not amenable to surgical treatment and cannot undergo curative radiotherapy or chemotherapy according to the 8th edition TNM staging classification of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer. 4.Absence of the following gene mutations: EGFR gene, ALK fusion oncogene, ROS1, etc. For other gene mutation types, patients without approved corresponding targeted therapies are allowed to be included. 5.Subjects must have received one prior systemic therapy for their malignant tumor. 6.Investigators have confirmed at least one measurable lesion according to RECIST 1.1 criteria. 7.Life expectancy = 3 months. 8.ECOG PS: 0-1. 9.Adequate hematologic function, defined as absolute neutrophil count = 1.5 × 10^9 /L, platelet count = 100 × 10^9 /L, hemoglobin = 90 g/L (no history of blood transfusion within 7 days). 10.Adequate hepatic function, defined as total bilirubin level = 1.5 times the upper limit of normal (ULN) and aspartate transaminase (AST) and alanine transaminase (ALT) levels = 2.5 times ULN in all patients, or = 5 times ULN for AST and ALT levels in patients with liver metastasis. 11.Adequate renal function, defined as serum creatinine = 1.5 times ULN. 12.Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; if the subject is receiving anticoagulant therapy, INR/PT should be within the range specified for the anticoagulant. 13.Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment; and reliable contraceptive measures (such as intrauterine devices, contraceptive pills, and condoms) should be used within 30 days before and after the start and end of the trial; male subjects of reproductive potential should use condoms for contraception during the trial and for 30 days after the end of the trial. 14.Regular follow-up and compliance with trial requirements are required.
Exclusion criteria
Exclusion criteria: 1.History of prior use of IDH1 drugs or other investigational drugs or treatments not yet marketed. 2.Known history of intolerance to PD-1 inhibitors treatment. 3.Receipt of any approved systemic anticancer therapy or systemic immune stimulant therapy within 28 days prior to the start of study treatment. 4.Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first dose. 5.History of allergic reactions to any components of the investigational drugs. 6.Known presence of brain metastases. Patients with stable brain metastases as determined by the investigator are eligible for inclusion. 7.Presence of active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention. 8.Presence of clinically uncontrolled pleural effusion/ascites (patients who do not require drainage of effusion or whose effusion has not significantly increased for 3 days can be included). 9.Tumor compression of vital organs (such as the esophagus) with accompanying symptoms, compression of the superior vena cava, or invasion of mediastinal great vessels, heart, etc. 10.Severe comorbidities such as a history of severe pulmonary or cardiac disease, occurrence of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or any other severe thrombotic event within 3 months before enrollment. 11.Receipt of systemic corticosteroids (>10 mg/d prednisone equivalent) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs [anti-TNF]) within 2 weeks before enrollment. The use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed. 12.History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes mellitus controlled after receiving stable insulin treatment are eligible to participate in this study. 13.Active systemic infections, including tuberculosis (clinical diagnosis including clinical history, physical examination, and radiographic findings, as well as TB tests according to local medical practice), hepatitis B (known positive for HBV surface antigen (HBsAg) and HBV DNA =1000cps/ml or its reference lower limit), hepatitis C, or human immunodeficiency virus (HIV antibody positive). 14.Known presence of psychiatric disorders or substance abuse that may affect compliance with trial requirements. 15.Existence of medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results, hinder subjects' full participation in the study, or are deemed by the investigator to not be in the best interest of the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Progression-Free Survival;Overall Survival; | — |
Countries
CHINA
Contacts
Public ContactChunxia Su
shanghai pulmonary hospital
Outcome results
None listed