Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07180862

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

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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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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