lung cancer
Conditions
Interventions
Test group:Denosumab + tislelizumab + docetaxel
Sponsors
Shanghai pulmonary hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age= 18 years old; (2) Patients with histologically or cytologically confirmed non-bone metastases stage IV NSCLC; (3) EGFR, ALK, and ROS1 are all wild-type (for other driver genes, if there is no first-line approval for corresponding targeted therapy or if the patient refuses targeted therapy, these patients are allowed to be enrolled); (4) first-line treatment with immune checkpoint inhibitors and clinical benefit (PFS = 3 months); (5) Have measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is =10mm, the short diameter of CT scan of lymph node lesions is =15mm, and the thickness of the scanning layer is not more than 5mm, and the measurable lesions have not received local treatment such as radiotherapy and cryotherapy); (6) ECOG PS: 0-2 points; (7) Estimated survival time= 3 months; (8) Adequate hematologic function, defined as absolute neutrophil count =1.5×109/L, platelet count = 80×109/L, hemoglobin = 90g/L (no history of blood transfusion within 7 days, not corrected with G-CSF and other hematopoietic stimulating factors); (9) adequate liver function, defined as total bilirubin levels =1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 times ULN, or for patients with liver metastases, AST and ALT levels = 5 times ULN; (10) adequate renal function, defined as creatinine clearance =50ml/min (Cockcroft-Gault formula); (11) Adequate coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; (12) For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug, and if the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; (13) If there is a risk of conception, male and female patients need to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment (Note: abstinence can be accepted as a contraceptive method if abstinence is the subject's usual lifestyle and preferred contraceptive method); (14) Subjects voluntarily joined this study, signed a written informed consent form before the implementation of any trial-related procedures, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1) Patients on first-line docetaxel chemotherapy; (2) Patients with symptomatic brain metastases (symptoms of brain metastases remain clinically stable for at least 1 month after treatment, and no steroids and anticonvulsants can be enrolled for at least 1 month before entering the study); (3) Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in effusion can be enrolled); (4) have not recovered adequately from toxicity and/or complications caused by any intervention (i.e., = grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment); (5) Diagnosis of other malignant tumors within 5 years before the first dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ that has undergone radical resection, if other malignant tumors or lung cancer are diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent metastatic lesions is required; (6) Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention; (7) Received solid organ or blood system transplantation; (8) Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia; (9) Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy; (10) Patients who need long-term systemic use of corticosteroids (patients who need intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroids due to COPD and asthma can be enrolled); (11) History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose; (12) Have an active infection requiring treatment or have used systemic anti-infective drugs within one week before the first dose; (13) Known psychiatric illness or substance abuse that may affect compliance with trial requirements; (14) Those who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Disease control rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai pulmonary hospital
Outcome results
None listed