The study is being conducted to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate vs. pembrolizumab in treatment naïve subjects with programmed death-ligand 1(PD-L1)-positive recurrent or metastatic non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.
pembrolizumab 200 mg.
Camrelizumab for injection, 200 mg.
PFS assessed by BIRC
Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: up to 3 years
PFS assessed by investigator
Progression-Free-Survival
Time frame: up to 3 years
ORR
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points
Time frame: up to 3 years
DCR
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: up to 3 years
DoR
Duration of Response, determined using RECIST v1.1 criteria
Time frame: up to 3 years
TTF
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Time frame: up to 3 years
AEs+SAEs
Adverse Events and Serious Adverse Events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
OS
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up
Time frame: up to 4 years
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
NOT_YET_RECRUITINGAnhui Chest Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
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