Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
Detailed description
This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
Interventions
DRUGBAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
DRUGEU-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
DRUGUS-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
DRUGPemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study
DRUGCarboplatin
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Participants are eligible to be included in the study only if all the following criteria are met: 1. Male or female, age ≥18 years on the day of signing informed consent. 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. Life expectancy ≥3 months, per the investigator's evaluation. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 5. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC. 6. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.
Exclusion criteria
* Participant must be excluded from participating in the study if the participant: 1. Is pregnant or a nursing female. 2. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 3. Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention. 4. Before the first dose of study intervention: * Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy * Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG3. * Has participated in any other BAT3306 study and has been treated with BAT3306. * Had major surgery \<3 weeks prior to first dose * Received radiation therapy to the lung that is \> 30 Gy within 6 months of the first dose of study intervention. * Completed palliative radiotherapy within 14 days of the first dose of study intervention. 5. Is expected to require any other form of antineoplastic therapy while participating in the study. and so on
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical equivalence | Week 3,5,7,9,12,15,EOT | To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of BAT3306 | From signed ICF to 90days after the last drug administration | The Investigator and any qualified designees are responsible for detecting, documenting, and reporting events that meet the definition of an AE or SAE and remain responsible for following up AE that are serious, considered related to the study intervention or the study, or that caused the participant to discontinue the study. |
Countries
China
Outcome results
None listed