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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title: An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210(Anti-PD-1 Antibody) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

In similar clinical trials, anti-PD-1 and anti-PD-L1 antibodies produce durable responses in approximately 20% of unselected patients with advanced non-small-cell lung cancer. Developing reliable, validated biomarkers that identify patients with an increased probability of response to these antibodies remains a challenge.

Because the PD-1 pathway may be a key mechanism of immune escape in a subgroup of patients with non-small-cell lung cancer, PD-L1 expression in tumor or inflammatory cells is a candidate biomarker. However, PD-L1 expression has not been formally validated as a biomarker in contemporaneously collected tumor tissue.

Additionally the purpose of the study is to assess the correlation between the expression of PD-L1 in the tumor and the response to treatment with SHR-1210 in non-small cell lung cancer. ;

Related Conditions & MeSH terms

• Bronchial Neoplasms
• Carcinoma
• Carcinoma, Bronchogenic
• Carcinoma, Non-Small-Cell Lung
• Lung Disease
• Lung Diseases
• Lung Neoplasms
• Neoplasm, Bronchial
• Neoplasms
• Respiratory Tract Disease
• Respiratory Tract Diseases
• Respiratory Tract Neoplasms
• Respiratory Tract Neoplasms Nec

• NCT number: NCT03085069
• Study type: Interventional
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 3, 2017
• Completion date: August 20, 2023