A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
NCT ID: NCT07180862
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2025-10-14
2027-11-30
Brief Summary
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Detailed Description
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Participants who meet all inclusion criteria and none of exclusion criteria will be randomized in an Interactive Web Response System (IWRS).
All participants will receive the investigational medicinal product at 200 mg via intravenous infusion every 3 weeks for a treatment period of up to 12 months . Serum samples will be collected from participants at specified time points for PK analysis to evaluate the PK similarity and PK characteristics of BAT3306 versus Keytruda®, while also assessing their immunogenicity and safety, and preliminarily comparing their improvement in disease-free survival (DFS).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BAT3306
Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
BAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
US-Keytruda® arm
Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
US-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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 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;
18 Years
75 Years
ALL
No
Sponsors
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Bio-Thera Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaorong Dong, Dr.
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BAT-3306-003-CR
Identifier Type: -
Identifier Source: org_study_id
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