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

NCT03085069 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-02-16

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

SHR-1210

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Shi, MD · Jiangsu Hengrui Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2020-08-20
Completion
2023-08-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085069 on ClinicalTrials.gov