A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC

Summary

This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment. Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(\<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks. The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.

Timeline

Start

2017-05-03

Primary completion

2020-08-20

Completion

2023-08-20

Publications

• Yang JJ, Huang C, Fan Y, Pan H, Feng J, Jiang L, Li XY, Liu XQ, Xiong JP, Zhao YQ, Cheng Y, Ma R, Wang J, Wang Y, Liu YH, Lin DM, Wang T, Shi W, Zou J, Wu YL. Camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic non-small cell lung cancer: a phase II study. Cancer Immunol Immunother. 2022 Jun;71(6):1393-1402. doi: 10.1007/s00262-021-03091-3. Epub 2021 Oct 20.

Drugs

Indications