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Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
506
Start Date
2024-03-15
Completion Date
2028-10-14
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
Pemetrexed
500 mg/m2 D1 IV Q3W
Carboplatin
AUC 5 or 6 mg/ml/min D1 IV Q3W
Paclitaxel
175 or 200 mg/m2 D1 IV Q3W
Sintilimab
200 mg D1 IV Q3W
Cisplatin
75 mg/m2 D1 IV Q3W
Nab paclitaxel
100 mg/m2 D1, 8, 15 IV Q3W
Placebo
20 ml D1 IV Q3W
Locations (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China