This is a phase II, open, single-center clinical study to evaluate the efficacy and safety of JS001 combined with Axitinib in the treatment of advanced non-small cell lung cancer without activated EGFR mutation, ALK fusion and ROS fusion after or during first-line chemotherapy. About 50 subjects will be included in this study and will be treated with JS001 combined with acitinib. Each cycle is 21 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The patients in the group will be infused intravenously with fixed dose of 240mg JS001 on the first day of each cycle. Oral Axitinib 5mg bid (recommended interval of about 12 hours) was given daily from the second day of the initial cycle
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
To evaluate the antitumor activity of Toripalimab injection (JS001) combined with Axitinib
The objective tumor reponse rate ((ORR)) evaluated by the investigator based on the solid tumor efficacy evaluation criteria (RECIST 1.1)
Time frame: From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.
To evaluate the efficacy of JS001 combined with Axitinib
Duration of response, disease control rate, time to reponse, and progression free survival, overall survival, 6-month progression-free survival ,6-month and 1-year survival.
Time frame: From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.
To evaluate the safety of JS001 combined with Axitinib
Overall incidence of adverse events (AE); The incidence of grade 3 or above AE; the incidence of severe adverse events (SAE); the incidence of drug-related AE; the incidence of AE resulting in permanent withdrawal of drugs; the incidence of AE leading to dose adjustment / suspension trial
Time frame: From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.
To evaluate the correlation between programmed death receptor-ligand 1 (PD-L1) expression and anti-tumor response in tumor tissues.
To evaluate the changes of TBNK lymphocyte subsets and the correlation analysis of antitumor activity under the treatment of JS001 combined with acitinib tablets,and the possible predictive factors of curative effect by biomarker analysis, including but not limited to tumor tissue lymphocyte infiltration, PMBC, PD-L1, TMB (using NGS/WES method).
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Time frame: From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.