Actively Recruiting
A Phase 1, Randomized, Double-blind Study Comparing Pharmacokinetics of BAT3306 and Keytruda in Participants With Stage IB-IIIA Non-small Cell Lung Cancer After Surgery
Led by Bio-Thera Solutions · Updated on 2026-01-06
140
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic similarity of BAT3306 and Keytruda as adjuvant treatments for participants with early-stage non-small cell lung cancer (NSCLC) who have undergone complete surgical removal of their cancer. This Phase 1, randomized, double-blind study focuses on participants without EGFR gene mutations or ALK gene rearrangements and who have not received prior radiotherapy or chemotherapy for this cancer. Participants will be randomly assigned to receive either BAT3306 or Keytruda through intravenous infusion at a dose of 200 mg every three weeks for up to one year, not exceeding 18 treatment cycles. The study includes two double-blind treatment groups and collects serum samples at specific time points to analyze pharmacokinetics, immunogenicity, and safety, while also providing preliminary data on disease-free survival. During the study, participants will undergo regular assessments including vital signs, physical exams, laboratory tests, and monitoring for adverse events at scheduled intervals throughout treatment. The main outcome measured is pharmacokinetic equivalence assessed at multiple days in the first treatment cycle, with additional evaluations across later cycles and weeks. The total participation duration may last up to one year, with continued safety and disease-free survival follow-up.
CONDITIONS
Brief 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 at the time of consent
- Able to give informed consent and willing to complete all study procedures
- Pathologically confirmed non-small cell lung cancer after surgery with clear histology 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
- Prior receipt of more than 4 cycles of adjuvant chemotherapy or neoadjuvant therapy
- Major surgery within 4 weeks before randomization or planned major surgery during the study
- Use of Chinese herbal medicine with anti-tumor effects within 14 days before randomization
- Use of growth factor support therapy or 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 requiring systemic anti-infective therapy within 2 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months (not exceeding 18 cycles)
Participants receive BAT3306 or Keytruda® via intravenous infusion every 3 weeks as adjuvant therapy after surgery.
Infusions every 3 weeks, with additional visits for assessments during and after cycles
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here