Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Detailed description
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 160 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).
Interventions
DRUGBAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
DRUGUS-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
double-blind, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) | Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0 |
| DFS（Disease-free survival） | Through study completion, No more than of 1 year | the duration of the absence of tumor recurrence or metastasis as per the RECIST 1.1 criteria. |
| immunogenicity equivalence | Weeks 1, 4, 10, 16, 22，34，52 | To evaluate the immunogenicity of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Anti-drug antibody (ADA) positive rate at Weeks 1, 4, 10, 16, 22，34，52 |
| Vital signs | The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) | Number of cases with abnormal vital signs results |
| Physical examination | The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) | Number of cases with abnormal Physical examination results |
| Laboratory Examination | The third and sixth weeks of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days) | Number of cases with abnormal Laboratory Examination results |
| PK equivalence | Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days） | To evaluate the PK characteristics of BAT3306 and US-Keytruda® in participants with completely resected NSCLC：Cthough |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaorong Dong, Dr.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed