RecruitingPhase 1NCT07180862
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
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
Sponsor
Bio-Thera Solutions
Enrollment
140 participants
Start Date
Oct 14, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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;
Exclusion Criteria9
- Participants who meet any of the following criteria will be excluded from the study:
- Presence of EGFR gene mutation;
- Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
- Have previously received any of the following treatments:
- Have received \> 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.
- Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.
- Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.
- Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.
- Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;
Interventions
DRUGBAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
DRUGUS-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07180862
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