Stage IIIB-IV non-small cell lung cancer
Conditions
Interventions
Treatment arm:sintilimab combined with vinorebine softgel metronomic chemotherapy
Sponsors
Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age greater than or equal to 75 years old or ECOG score of 2, gender is not limited; 2. patients with pathologically (histologically or cytologically) confirmed driver gene-negative non-small cell lung cancer (NSCLC) with clinical stage IIIB to IV (according to AJCC 8th edition TNM staging criteria); 3. have not received any prior systemic therapy for locally advanced/late-stage NSCLC and have refused or are intolerant to intravenous chemotherapy; 4. have at least one measurable lesion that meets RECIST 1.1 criteria; 5. have normal vital organ function, i.e., meet the following criteria: Routine blood tests must be consistent with (no transfusion, no hematopoietic factor use and no drug correction within 14 days): 1) WBC =4.0×109/L; 2) ANC = 2 × 109/L; 3) PLT = 100 × 109/L; 4) HB = 90 g/L; Biochemical examination must meet the following criteria: 1) TBIL = 1.5 × upper limit of normal (ULN); 2) ALT, AST = 2.5 × ULN; (if liver metastasis exists, ALT, AST = 5 × ULN); 3) Serum creatinine = 1.5 × ULN, creatinine clearance = 50 mL/min (Cockcroft-Gault formula); 4) cardiac function: echocardiographic LVEF = 50%; 6. life expectancy greater than or equal to 3 months; 7. female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study drug and be willing to use a medically approved, highly effective method of contraception (e.g., IUD, birth control pills, or condoms) for the duration of the study and for a period of 6 months following the final administration of study drug; and, in the case of male subjects with a partner of childbearing potential, agree to use a highly effective method of contraception for the duration of the study and for a period of 6 months following the final administration of study drug. months after the last study dose; 8. Subjects voluntarily enroll in the study and sign an informed consent form, comply well and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. other primary malignancy within the past 3 years (except for non-melanoma skin cancer, cured localized prostate cancer, cervical carcinoma in situ, or squamous epithelial endothelial lesions on PAP smear) 2. known presence of brain or meningeal disease, including history of epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system 3. have any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of study drug; 4. being treated with other systemic antineoplastic drugs or investigational drugs 5. have had an arterial/venous thrombotic event such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months, or therapeutic anticoagulant therapy with warfarin or heparin 6. severe cardiovascular disease: grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting a left ventricular ejection fraction (LVEF) <50%; 7. human immunodeficiency virus (HIV) infection or other uncontrolled active infection; 8. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (at least once a month) 9. the presence of any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a history of a known allogeneic transplantation, or a patient who is a chronic heavy user of hormones or on other immunomodulators, or other patients who are evaluated by the investigator as having a potential for patients who have an impact on study treatment; 10. history of interstitial lung disease or uncontrolled systemic disease, including diabetes mellitus, hypertension, acute lung disease, etc; 11. surgery (including open biopsy, surgical resection, wound repair, or any other major surgery involving entry into a body cavity) or major trauma within 28 days prior to treatment in this study, or anticipation of the need for major surgery during the treatment phase of the study 12. allergy to any study drug or excipient; 13. the presence of an underlying medical condition or alcohol/substance abuse or dependence that is not conducive to the administration of the study medication, or that may interfere with the interpretation of results, or that places the patient at high risk of developing treatment complications 14. concurrent participation in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,DCR;Clinical benefit rate,CBR;Duration of response,DoR;Overall Survival, OS;Progression-free survival, PFS;Quality of Life, QoL; | — |
Countries
China
Contacts
Public ContactJianchun Duan, Wenzhong Su
Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed