NCT03607539

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Sintilimab	10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.
DRUG	Pemetrexed	500mg/m\^2; Q3W (qualer 3 weeks), day1, I.V.
DRUG	Platinum	Q3W (qualer 3 weeks), day1, I.V.; first 4 cycles.
DRUG	Placebos	10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.

Timeline

• Start date: 2018-08-23
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2018-07-31
• Last updated: 2023-02-27
• Results posted: 2021-02-16

Locations

1 site across 1 country: China