This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
390
Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Anhui Chest Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, China
Progression-free survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: up to 24 month
Progression-free survival
Progression-free survival (PFS) assessed by investigators according to RECIST V 1.1
Time frame: up to 24 month
Overall Survival (OS)
defined as time from the randomized to the time of the patient's death from any reason assessed by researchers.
Time frame: up to 24 month
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 24 month
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 24 month
Duration of response (DoR)
According to Recist v 1.1 accessed by investigators
Time frame: up to 24 month
Adverse events (AEs)
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03
Time frame: up to 24 month
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The Seventh Medical Center of PLA Ceneral Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
900TH Hospital of Joint Logistics Support Force
Fuzhou, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
...and 43 more locations