NCT05116462

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

A Randomized, Double-blind, Phase 3 Study of the Efficacy and Safety of Sindilizumab Combined With Chemotherapy or Placebo Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer (ORIENT-99)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	500 mg/m2 D1 IV Q3W
DRUG	Carboplatin	AUC 5 or 6 mg/ml/min D1 IV Q3W
DRUG	Paclitaxel	175 or 200 mg/m2 D1 IV Q3W
DRUG	Sintilimab	200 mg D1 IV Q3W
DRUG	Cisplatin	75 mg/m2 D1 IV Q3W
DRUG	Nab paclitaxel	100 mg/m2 D1, 8, 15 IV Q3W
DRUG	Placebo	20 ml D1 IV Q3W

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-09-30
• Completion: 2028-10-14
• First posted: 2021-11-11
• Last updated: 2025-06-26

Locations

1 site across 1 country: China