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)
PK equivalence — Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days) To compare the pharmacokinetic (PK) similarity of BAT3306 versus US-Keytruda® as adjuvant therapy in participants with completely resected NSCLC:AUC0-τ, ss
Trial sites (1)
Facility
City
Region
Status
Union Hospital Tongji Medical College Huazhong University of Science & Technology
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.
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