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A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
Sponsor: Bio-Thera Solutions
Summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Official title: A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-10-14
Completion Date
2027-11-30
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
BAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
US-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Locations (1)
Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China