MedTrace Logo

A Study of SHR-1210 in Combination With Pemetrexed and Carboplatin in Subjects With Non-squamous NSCLC

NCT03134872 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2020-06-09

No results posted yet for this study

Summary

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a randomized,Phase III, multicenter ,open-label study designed to evaluate the safety and efficacy of SHR-1210 with carboplatin and pemetrexed versus carboplatin-pemetrexed in subjects who are chemotherapy naive and have Stage IIIB/IV non-squamous NSCLC.

The primary hypothesis is that SHR-1210 combined with carboplatin and pemetrexed prolongs Progression Free Survival (PFS) in per RECIST 1.1 by blinded independent central review (ITT population and population was indicated by high PD-L1 expression) compared to carboplatin and pemetrexed treatment .

Conditions

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

Interventions

BIOLOGICAL

SHR-1210

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

DRUG

Carboplatin

Carboplatin

DRUG

Pemetrexed

Pemetrexed

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Shi, MD · Jiangsu HengRui Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2019-07-27
Completion
2019-08-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03134872 on ClinicalTrials.gov