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Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC

Lung Neoplasms Clinical Trial

Official title:
A Randomized, Double-blinded, Phase III Study of Pemetrexed Plus Platinum Chemotherapy With or Without Sintilimab (IBI308) in First Line Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (Orient-11)

Clinical Trial Summary

Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC

Clinical Trial Description

Sintilimab is expected to increase the PFS from 6 months to 9.2 months. Anti-PD-1 therapy in Chinese non-squamous NSCLC naïve patients will be investigated in this clinical trial. Additionally the correlation between PD-L1 expression and the response to Sintilimab treatment in Chinese non-squamous NSCLC as well as the role of iRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03607539
Study type Interventional
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact
Status Completed
Phase Phase 3
Start date August 23, 2018
Completion date February 13, 2023
View Details
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