Actively Recruiting
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
Led by Bio-Thera Solutions · Updated on 2026-01-06
140
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
CONDITIONS
Official Title
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years on the day of signing the informed consent
- Able to give voluntary informed consent and willing to complete all study procedures
- Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery with a clear histological type and pathology report provided
You will not qualify if you...
- Presence of EGFR gene mutation
- Diagnosis of small cell lung cancer, mixed tumors with small cell components, large cell neuroendocrine carcinoma, or sarcomatoid tumors
- Previously received more than 4 cycles of adjuvant chemotherapy or prior neoadjuvant therapy
- Major surgery within 4 weeks before randomization or expected major surgery during the study (excluding vascular access procedures)
- Use of Chinese herbal medicine with anti-tumor effects within 14 days before randomization
- Use of growth factor support therapy or blood transfusion within 14 days before randomization
- Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or other immunomodulatory agents
- Severe acute or chronic infection, including active infection requiring systemic anti-infective therapy within 2 weeks before randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yu Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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