To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell lung cancer.
Name: SCT510
Description: SCT510 InjectionType: DrugSCT510 combined paclitaxel and carboplatin
Name: Bevacizumab
Description: Bevacizumab InjectionType: DrugBevacizumab combined paclitaxel and carboplatin
Name: Paclitaxel
Description: Paclitaxel InjectionType: DrugSCT510 combined paclitaxel and carboplatin Bevacizumab combined paclitaxel and carboplatin
Name: Carboplatin
Description: Carboplatin injectionType: DrugSCT510 combined paclitaxel and carboplatin Bevacizumab combined paclitaxel and carboplatin
Description: the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria
Measure: Objective response rate Time: 12 weeksDescription: the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria
Measure: Objective response rate Time: 18 weekDescription: the proportion of subjects with CR（complete response）, PR（partial response） and SD（Stable disease） combined，according to RECIST 1.1 criteria
Measure: Disease control rate Time: 12 weeks and 18 weeksDescription: The time from the first assessment of CR（complete response） or PR（partial response） to the first assessment of PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria
Measure: Duration of Response Time: 3 yearsDescription: The time from randomization to PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria
Measure: Progression free survival Time: 3 yearsDescription: The proportion of subjects who survived longer than 1 year after randomization
Measure: 1-year overall survival rate Time: 1 yearDescription: Defined as the time from randomization of subjects to death from any cause
Measure: Overall survival Time: 3 yearsAllocation: Randomized
Parallel Assignment
There are 2 SNPs
21 (L858R, L861Q)) and ALK fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need to undergo genetic testing during the screening period.Among them, subjects whose EGFR or ALK gene status cannot be determined for various reasons can be enrolled;Subjects who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled if they are currently unable to obtain the corresponding targeted drugs (including the rejection of the subjects) and chemotherapy is standard treatment at the research center; 5. --- L858R ---
21 (L858R, L861Q)) and ALK fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need to undergo genetic testing during the screening period.Among them, subjects whose EGFR or ALK gene status cannot be determined for various reasons can be enrolled;Subjects who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled if they are currently unable to obtain the corresponding targeted drugs (including the rejection of the subjects) and chemotherapy is standard treatment at the research center; 5. --- L858R --- --- L861Q ---