NCT03802240

Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 492 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab	200mg IV Q3W
DRUG	IBI305	15mg/kg IV Q3W
DRUG	Pemetrexed	500mg/m2 IV Q3W
DRUG	Cisplatin	75mg/m2 IV Q3W
DRUG	Placebo1	Placebo1 IV Q3W
DRUG	Placebo2	Placebo2 IV Q3W

Timeline

• Start date: 2019-07-11
• Primary completion: 2021-07-31
• Completion: 2023-06-30
• First posted: 2019-01-14
• Last updated: 2023-11-27

Locations

1 site across 1 country: China