Lung Cancer
Conditions
Interventions
single arm treatment group:Adbelimumab: 1200mg Q3W, intravenous infusion, every 3 weeks, given on the first day for up to 2 years.
Antirotinib: Oral, 8mg Qd, taken orally before breakfast for 2 weeks,
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all of the following inclusion criteria: 1. Age: >= 18 years old; 2. advanced NSCLC confirmed by pathology (including histology or cytology); 3. Gene test positive for STK11 or KEAP1 mutation; 4. Negative driver genes for first-line targeted therapy, including but not limited to EGFR, ALK, ROS1, MET, RET; 5. Has measurable lesions (according to the RECIST 1.1 cr, the diameter of tumor lesions should be >= 10mm in CT scan, the diameter of lymph node lesions should be >= 15mm in CT scan, the scan layer thickness should not be greater than 5mm, and the lesions can be measured as having not received local treatment such as radiotherapy or freezing); 6. ECOG PS: 0-1 score; 7. Expected survival >= 3 months; 8. Adequate hematological function, defined as absolute neutrophil count >= 1.5×10^9/L, platelet count >=80×10^9/L, hemoglobin >=90g/L (no blood transfusion history within 7 days, no G-CSF and other hematopoietic stimulating factors to correct); 9. Adequate liver function, defined as all patients with total bilirubin levels = 45ml/min (Cockcroft-Gault formula); 11. Adequate coagulation function, defined as International Standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR/PT is within the prescribed range of anticoagulants; 12. The subjects voluntarily joined the study, signed a written informed consent prior to the implementation of any procedures related to the trial, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions were excluded from the study: 1. is currently participating in an interventional clinical study or has received another investigational drug or investigational device within 4 weeks prior to initial dosing; 2. previous treatment with anti-PD-1, anti-PD-L1 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA4, OX-40, CD137); 3. received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose; 4. Active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; 5. Known or screening tests reveal active central nervous system (CNS) metastases and/or cancerous meningitis; 6. Grade III-IV congestive heart failure (New York Heart Association rating), poorly controlled and clinically significant arrhythmias; 7. Severe arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to treatment. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment. 8. known allergic reactions to the active ingredient and/or any excipients of PD-L1 monoclonal antibody; 9. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 10. A history of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to initial administration; Active interstitial lung disease. Patients requiring long-term systemic use of corticosteroids. Patients with intermittent use of inhaled corticosteroids or local injection of corticosteroids could be enrolled; 11. diagnosed with other malignancies within 5 years prior to initial dosing, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ; 12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis; 13. untreated active hepatitis B; Note: Participants with hepatitis B who met the following criteria were also eligible for inclusion: HBV viral load prior to initial administration must be <1000 copies /ml (200 IU/ml) or below the lower limit of detection, and participants should receive anti-HBV therapy to avoid viral reactivation throughout study chemotherapy therapy. 14. there is a medical history, illness, treatment, or abnormal laboratory results that could interfere with the test results or prevent the subject from fully participating in the study, or the investigator believes that participation in the study is not in the subject's best interest;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;quanlity of life;duration of response;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactFengying Wu
Shanghai Pulmonary Hospital
Outcome results
None listed