Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early stage NSCLC. Participants must have no EGFR gene mutation or ALK gene rearrangement, have not received neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy, and have no plans for such treatment. A total of approximately 140 eligible participants will be randomly assigned in a 1:1 ratio to 2 double-blind treatment groups. 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
One vial of 4 mL of concentrate contains 100 mg of BAT3306
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGPK equivalence
To compare the pharmacokinetic (PK) similarity of BAT3306 versus US-Keytruda® as adjuvant therapy in participants with completely resected NSCLC:AUC0-τ, ss
Time frame: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)
PK equivalence
To evaluate the PK characteristics of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Cthough
Time frame: Cycle 1,2,3,4,5,6,8,12,18(each cycle is 21 days)
immunogenicity equivalence
To evaluate the immunogenicity of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Anti-drug antibody (ADA) positive rate at Weeks 2, 4,12,18,24
Time frame: Weeks 2, 4,12,18,24
Vital signs
Number of cases with abnormal vital signs results
Time frame: The third week of every 4 cycles and EOT(No more than 18 cycles)(each cycle is 21 days)
Physical examination
Number of cases with abnormal Physical examination results
Time frame: The third week of every 4 cycles and EOT(No more than 18 cycles)(each cycle is 21 days)
Laboratory Examination
Number of cases with abnormal Laboratory Examination results
Time frame: The third and sixth weeks of every 4 cycles and EOT(No more than 18 cycles)(each cycle is 21 days)
Adverse event
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
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Time frame: The third week of every 4 cycles and EOT(No more than 18 cycles)(each cycle is 21 days)
DFS(Disease-free survival)
the duration of the absence of tumor recurrence or metastasis as per the RECIST 1.1 criteria.
Time frame: Through study completion, No more than of 1 year