Metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Tislelizumab plus docetaxel
Sponsors
The First People’s Hospital of Jingzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed NSCLC not suitable for radical surgery or radiotherapy (AJCC ninth edition TNM stage); 2. No known EGFR mutations or ALK and ROS1 rearrangements; 3. Progression of previous first-line anti-PD-(L)1 antibody combined with platinum-containing doublet chemotherapy for metastatic NSCLC; 4. First-line treatment PFS>=84 days; 5. At least 1 measurable lesion determined by the investigator according to RECIST v1.1 (measurable lesion has not received radiotherapy); 6. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) =1.5×10^9/L; 2) Platelets>=80×10^9/L; 3) Hemoglobin >=90g/L; (2) Serum creatinine =60mL/min/1.73m^2; (3) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5× ULN, alkaline phosphatase should be <=2.5×ULN; (4) Serum total bilirubin <=1.5×ULN; (5) International normalized ratio (INR) <=1.5×ULN or prothrombin time (PT) <=1.5×ULN; (6) Activated partial thromboplastin time (aPTT) <=1.5×ULN; 8. Able to provide written informed consent and understand and agree to comply with the study requirements and assessment plan; 9. Age 18~75 years old at the time of signing the informed consent form; 10. Patients of childbearing potential must be willing to take highly effective contraceptive measures during the study and within 120 days after the last dose of tislelizumab.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with docetaxel; 2. Prior immunotherapy other than anti-PD-(L)1 antibodies, including but not limited to anti-CTLA-4, anti-TIGIT, anti-OX40, and anti-PD-(L)1/VEGF bispecific antibodies; 3. Previous antivascular drug therapy; 4. Toxicities from prior antineoplastic therapy have not returned to baseline or stabilized (with the exception of adverse events that are unlikely to pose a safety risk, such as alopecia, neuropathy, or abnormal results of specific laboratory tests). 5. Unacceptable toxicity after prior anti-PD-(L)1 antibody therapy, defined as follows: (1) =Grade 3 AEs related to anti-PD-1/PD-L1 therapy, and standard therapy is ineffective and treatment needs to be discontinued; Grade =2 imAEs related to anti-PD-(L)1 antibody therapy, unless the AE has recovered or is well controlled after suspension of anti-PD-(L)1 antibody therapy and/or steroid therapy, with the exception of prior colitis, encephalitis, myocarditis, hepatitis, uveitis, and pulmonary inflammation; and (2) central nervous system (CNS) or ocular AEs of any grade associated with anti-PD-(L)1 antibodies. (Note: Patients with prior endocrine AEs are allowed to receive the first dose of study drug if they are able to remain stable and asymptomatic after appropriate replacement therapy); 6. Have meningeal metastases caused by metastatic NSCLC, or have active brain metastases. Note: Patients who are stable at screening will only be eligible for inclusion if they meet all of the following criteria: (1) There was no evidence of immediate progression on brain imaging at screening, and there was no evidence of new brain metastases for at least 2 weeks; (2) measurable lesions and/or evaluable disease other than the CNS; (3) Current absence of corticosteroids for the treatment of CNS disease, discontinuation of steroids 3 days prior to the first dose of study drug, and use of stable doses of anticonvulsants is allowed. 7. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence after intervention 9. Patients who have received any Chinese herbal or proprietary Chinese medicine treatment for cancer control within 14 days before the first dose of study drug; 10. Patients with active autoimmune diseases or a history of autoimmune diseases that may recur; 11. Any condition requiring systemic treatment with corticosteroids (prednisone at a dose higher than 10mg/d or equivalent dose of similar drugs) or other immunosuppressive agents =500 IU/mL (HBV DNA testing is only performed for patients who are positive for anti-HBc antibodies); (2) Patients with positive HCV RNA test (only HCV RNA testing is performed on patients with positive HCV antibody); 14. Patients who are all
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR);Objective response rate (ORR);Progression Free Survival (PFS);safety;Overall survival;Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactZhiqiang Cai
The First People’s Hospital of Jingzhou
Outcome results
None listed