Status:
RECRUITING
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
Lead Sponsor:
Bio-Thera Solutions
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Detailed Description
This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early st...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07180862
Start Date
October 14 2025
End Date
November 30 2027
Last Update
January 6 2026
Active Locations (1)
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1
Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China