Abstract 3328
Background
SHR-1210 is a humanized anti–PD-1 antibody, with immunoglobulin gamma 4 (IgG4) as heavy chain and immunoglobulin kappa (IgK) as light chain expressed in the supernatant of a Chinese hamster ovary (CHO) stable cell line. Antitumor activity data for the ongoing clinical studies of SHR-1210 are currently being evaluated. SHR-1210 is currently being tested in 15 studies in advanced malignancies: 4 in advanced solid tumors, 3 in NSCLC, 2 in hepatocellular cancer (HCC; including 1 in HCC or gastric cancer [GC]), 2 in esophageal cancer (EC), 1 in melanoma, 1 in nasopharyngeal cancer (NPC), 1 in primary liver cancer (PLC), and 1 in classic Hodgkin lymphoma (cHL). Since 22 MAY 2017, 395 patients have been enrolled in this trial.
Trial design
In this trial, 412 patients will be randomly assigned in a 1:1 ratio, to receive either carboplatin-pemetrexed chemotherapy,OR receive SHR-1210 combined with carboplatin-pemetrexed chemotherapy. Randomization will be stratified according to gender and smoking history. All the patients will receive carboplatin(area under the curve 5) plus pemetrexed(500 mg/m2), all administered as IV infusion on Day 1 of each 3-week cycle for 4 or 6 cycles of the investigator's choice, followed by pemetrexed(500 mg/m2) every 3 weeks(Q3W) maintenance for the remainder of the study. Patients assigned to the SHR-1210 combined with chemotherapy arm, will additionally receive SHR-1210(200mg) administered as IV infusion on Day 1 of each 3-week cycle, for up to 35 cycles. Patients assigned to the chemotherapy arm will have the opportunity to crossover to receive SHR-1210(200mg) monotherapy every 3 weeks(Q3W) once they experience progression of disease (PD) defined by RECIST 1.1 and meet all crossover criteria.
Clinical trial identification
NCT03134872.
Legal entity responsible for the study
Jiangsu HengRui Medicine Co., Ltd.
Funding
Jiangsu HengRui Medicine Co., Ltd.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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