To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
One vial of 4 mL of concentrate contains 100 mg of BAT3306
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
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
clinical equivalence
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)
Time frame: Week 3,5,7,9,12,15,EOT
safety of BAT3306
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.
Time frame: From signed ICF to 90days after the last drug administration
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500 mg/m2 on Day 1 of each 21-day cycle of the study
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles