The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
762
Camrelizumab 200mg q2w ivgtt
Apatinib Mesylate 250mg po qd
Pemetrexed disodium for injection 500 mg/m2 q3w
Progression Free Survival (PFS) assessed by Independent review committee (IRC)
Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.
Time frame: up to 2 years
Overall survival
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Time frame: up to 2 years
PFS assessed by investigator
Progression-Free-Survival
Time frame: up to 2 years
Objective Response Rate
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Time frame: At the time point of every 6 weeks,up to 2 years
Disease Control Rate
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: At the time point of every 6 weeks,up to 2 years
Duration of Response
Duration of Response, determined using RECIST v1.1 criteria
Time frame: Up to 2 years
Time to Treatment Failure
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Time frame: Up to 2 years
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Paclitaxel injection 175 mg/m2 q3w
Carboplatin AUC 5 mg/mL/min q3w
Adverse Events and Serious Adverse Events
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 90 days for the last Camrelizumab dose