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)

Union Hospital Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

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NCT07180862


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