The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.
The study is being conducted to evaluate the efficacy and safety of Camrelizumab in combination with Famitinib plus chemotherapy in subjects with NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Part 1: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo
Beijing Cancer Hosipital
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospita
Wuhan, Hubei, China
Shengjing Hospita of China Medical University
Shenyang, Liaoning, China
Part 1:Serum concentrations of Camrelizumab
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Plasma concentrations of Famitinib
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib.
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Maximum Concentration (Cmax) of Famitinib.
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Time to Maximum Concentration (Tmax) of Famitinib.
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Half-life (t1/2 z) of Famitinib.
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Apparent Clearance (CL/F) of Famitinib
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Vz/F of Famitinib.
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1.
Time frame: up to 24 months
Part 1:Objective Response Rate (ORR) as Assessed by investigators
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
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Shanghai Lung Hospital
Shanghai, Shanghai Municipality, China
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Part 1:Duration of Response (DOR) as Assessed by investigators
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Progression-free Survival (PFS) as Assessed by investigators
Time frame: Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Overall Survival (OS).
Time frame: Up to approximately 60 months
Part 2:Overall Survival (OS)
Time frame: Up to approximately 60 months
Part 2:Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1.
Time frame: up to 24 months
Part 2:Objective Response Rate (ORR) as Assessed by investigators and BICR according to RECIST 1.1
Time frame: up to 24 months
Part 2:Duration of Response (DOR) as Assessed by investigators and BICR according to RECIST 1.1
Time frame: up to 24 months
Part 2:Disease Control Rate(DCR) as Assessed by investigators and BICR according to RECIST 1.1
Time frame: up to 24 months
Part 2:Number of Participants With Adverse Events and Serious Adverse Event as Assessed by CTCAE v5.0.
Time frame: up to 24 months