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Clinical Trials in China / NCT07180862
Active, not recruiting Phase 1

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

NCT07180862 · tracked via the Priya Life Science China tracker
Sponsor
Bio-Thera Solutions
Phase
Phase 1
Started
2025-10-14
Last updated
2026-09-02

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

BAT3306US-Keytruda®

BAT3306: One vial of 4 mL of concentrate contains 100 mg of BAT3306

US-Keytruda®: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Study summary

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Participants must meet all of the following criteria: 1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF); 2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures; 3. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided; Exclusion Criteria: * Participants who meet any of the following criteria will be excluded from the study: 1. Presence of EGFR gene mutation; 2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors; 3. 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. 4. Prior anti-tumor treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents. 5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Union Hospital Tongji Medical College Huazhong University of Science & Technology Wuhan Hubei

More Bio-Thera Solutions trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07180862 on ClinicalTrials.gov ↗ ← All trials in China