This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Subjects receive SHR-1210 intravenous every 2 weeks
Subjects receive Apatinib orally every day
Subjects receive Pemetrexed intravenous every 3 weeks
subjects receive carboplatin intravenous every 3 weeks
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee Using RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Time frame: up to approximately 40 months
Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Time Frame: Baseline until PD or death, whichever occurs first
Time frame: up to approximately 40 months
Duration of Overall Survival (OS)
Baseline until death from any cause
Time frame: up to approximately 40 months
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.
Time frame: up to approximately 40 months
disease control rate (DCR)
The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1.
Time frame: up to approximately 40 months
Duration of response (DoR)
Duration of response (DoR)
Time frame: up to approximately 40 months
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Time frame: up to approximately 40 months
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