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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Participants must meet all of the following criteria:
‣ Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);
⁃ Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;
⁃ Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;
Locations
Other Locations
China
Union Hospital Tongji Medical College Huazhong University of Science & Technology
RECRUITING
Wuhan
Contact Information
Primary
Yu Sun
yusun@bio-thera.com
86-15040223137
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 140
Treatments
Experimental: BAT3306
Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
Active_comparator: US-Keytruda® arm
Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
Related Therapeutic Areas
Sponsors
Leads: Bio-Thera Solutions