non-small cell lung cancer (NSCLC)
Conditions
Interventions
case series:None
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. NSCLC diagnosed by pathology (including histology or cytology); 3. Patients with stage IIIB or IV or postoperative recurrence who were unresectable and unable to tolerate radical chemoradiotherapy according to TNM version 8; 4. For patients with EGFR mutation, patients with TKI resistance and no T790M mutation were allowed to be included and were designated to receive tririplizumab combined with pemetrexed and carboplatin; 5. Measurable lesions (according to RECIST 1.1, the CT scan diameter of tumor lesions is >=10mm, the CT scan diameter of lymph node lesions is >=15mm, and the scan thickness is not more than 5mm); 6. ECOG PS: 0-2 points; 7. Estimated survival time >=3 months; 8. Adequate hematological function was defined as absolute neutrophil count >=1.5x10^9/L, platelet count >=80x10^9/L, hemoglobin >=90 G /L (no history of blood transfusion within 7 days, no use of granulocyte colony-stimulating factor (G-CSF) and other hematopoietic stimulating factors to correct); 9. Adequate liver function was defined as total bilirubin level =50ml/min (Cockcroft-Gault formula); 11. Adequate coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the patient is on anticoagulant therapy, as long as the INR/PT is within the prescribed range for anticoagulants; 12. For female patients of reproductive age, a negative urine or serum pregnancy test should be performed within 3 days prior to the initial administration of the study drug, and if the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test should be requested; 13. If there is a risk of conception, male and female patients should use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) for at least 180 days after discontinuation of trial treatment; Note: If abstinence is the patient's usual lifestyle and preferred contraceptive method, abstinence is acceptable as a contraceptive method; 14. Volunteer to participate in the study, sign written informed consent before the implementation of any trial-related procedures, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Currently participating in an interventional clinical study treatment or receiving other study drugs or study devices within 4 weeks prior to the first dose; 2. Previous immunotherapy, including but not limited to immune checkpoint inhibitors, adoptive immune cell therapy, tumor vaccines, etc.; 3. Received proprietary Chinese medicine 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. The presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis requiring clinical intervention; 5. Have received solid organ or blood transplantation; 6. Class II-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; 7. An active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; 8. Patients requiring long-term systemic corticosteroid use. Patients with chronic obstructive pulmonary disease or asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections were enrolled; 9. Other malignant tumors were diagnosed within 5 years before the first administration, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and/or radical resected carcinoma in situ. If other malignant tumors or lung cancer were diagnosed more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions was required; 10. A history of noninfectious pneumonia requiring corticosteroid treatment within 1 year before the first dose or current noninfectious pneumonia; 11. Active infection requiring treatment or use of systemic anti-infective drugs within one week before the first dose; 12. A known mental illness or substance abuse condition that may affect compliance with trial requirements; 13. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known syphilis infection (syphilis antibody positive), active tuberculosis; 14. Untreated active hepatitis B; Note: patients with hepatitis B were eligible if they met the following criteria: their HBV viral load must be less than 1000 copies per milliliter (200 IU per milliliter) or below the lower limit of detection before the first dose, and they should receive anti-HBV therapy to avoid virus reactivation throughout the study period of chemotherapy drug therapy. Patients with anti-HBC (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not need prophylactic anti-HBV therapy, but need to be closely monitored for virus reactivation; 15. Active HCV-infected patients (HCV antibody positive with HCV-RNA levels above the lower limit of detection); 16. Had received live vaccine within 30 days prior to the first dose; Note: Inactivated injectable virus vaccines against seasonal influenza (including COVID-19 vaccines) are permitted; However, they are not allowed to receive live attenuated influenza vaccines administered intranasally; 17. Abnormal medical history, disease, treatment, or laboratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Incidence of immune-related adverse reactions; | — |
Countries
China
Contacts
Public ContactSu Chunxia
Outcome results
None listed