lung cancer
Conditions
Interventions
Treatment group:Tislelizumab 200mg on day 1 + Paclitaxel polymer micelles 230mg/m^2 on day 1 + Carboplatin AUC5 on day 1 every 3 weeks
Sponsors
Mianyang Central Hospital, Affiliated Hospital of University of Electronic Science and Technology of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and <= 75 years; 2. Patients with locally advanced or metastatic squamous NSCLC confirmed by histology or cytology according to the 8th Edition of the TNM Classification of Lung Cancer published by the International Association for the Study of Lung Cancer and the Union for International Cancer Control; 3. At least one measurable lesion for the investigator to evaluate the disease response according to RECIST V1.1; 4. PS score of 0 to 2; 5. No previous systemic anti-tumor treatment; for patients with disease progression after previous local anti-tumor treatment, if the disease progression occurs more than 6 months after the last treatment, they are eligible for the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known positive driver genes (such as epidermal growth factor receptor (EGFR) sensitive mutations or anaplastic lymphoma kinase (ALK) rearrangement or ROS1 gene fusion); 2. Currently participating in an interventional clinical study, or receiving another investigational drug or equipment within 4 weeks before the first administration; 3. Having uncontrollable pleural effusion/ascites (patients who do not need to have the fluid drained or whose fluid volume does not significantly increase after 3 days of stopping the drainage can be enrolled); 4. Having symptomatic central nervous system metastasis. Patients with asymptomatic brain metastasis or stable symptoms after treatment (maintaining clinical stability for at least 2 weeks) can participate in this study; 5. Having received solid organ transplantation or blood transplantation; 6. Having grade III-IV congestive heart failure (based on the New York Heart Association classification) or poorly controlled and clinically significant arrhythmia; 7 Having severe liver or kidney dysfunction, and the investigator assesses that the patient has contraindications to chemotherapy or immunotherapy; 8. Within 2 years before the first administration, having active autoimmune diseases requiring systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological doses of corticosteroids for treating adrenal or pituitary insufficiency) are not considered systemic; 9. Having known mental disorders or drug abuse that may affect compliance with the trial requirements; 10. Having a known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies), syphilis infection (positive syphilis antibody), or active tuberculosis; 11. Having untreated active hepatitis B; Patients with hepatitis B who meet the following criteria are also eligible for inclusion: Before the first administration, the hepatitis B virus (HBV) load must be lower than 1000 copies/mL (200 IU/mL) or below the limit of detection (LLD), and the subject should receive anti-HBV treatment to avoid viral reactivation throughout the study period; For HBcAb (+), HBsAg (-), HBsAb (-), and HBV load (-) subjects, close monitoring is required instead of preventive anti-HBV treatment to avoid viral reactivation; Patients with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above LLD); 12. Pregnant or lactating patients; 13. Known to be allergic to tiragolumab, the active ingredient of paclitaxel, and/or any excipients; 14. The investigator considers that participating in this study is not in the best interests of the subject;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Overall survival; | — |
Countries
China
Contacts
Public ContactJunhua Wu
Mianyang Central Hospital, Affiliated Hospital of University of Electronic Science and Technology of China
Outcome results
None listed